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Fischer Imaging Corp.

United StatesFDA applicant, unverified

Devices
69
FDA recalls
11

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue69

Newest first, rows 1-50 of 69

Search and filter all 69 devices
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  • Radiographic Floor Mounted Tubestand Fm 60 Ref K893652

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Rms 180 Ref K893673

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Elite R 90/15 Ref K912741

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fvp-1000 Family And Fvp-1000D Family Ref K905694

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mammopath Ref K021113

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Imager Ref K883831

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Single Phase Diagnostic X-Ray Generator Fx-650 Ref K880521

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ep-X Ref K934481

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mammotest Product, Modification Ref K926575

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mammotest Adapter Driver Ref K973400

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Three Phase, Diagnostic Generator Micro-X 75 Ref K880523

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Revelation, Radio Fluoroscopic X-Ray Exam Table Ref K874901

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Linus Ref K812398

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Athena-Hf Mammographic X-Ray System Ref K900989

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro X-65 Hf Ref K944150

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Epic (Electrophysiology Imaging Computer Ref K926560

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lc Positioner Ref K981414

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro-X 80HF Ref K905695

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mammoscan Ref K923061

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mobile Athena Hf Ref K922454

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tangent Vi Table Ref K961022

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fischer Pps/Mammotest Mammography System Ref K861692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tangent Ii Ref K883974

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rme 325R Ref K893674

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tangent V Ref K915853

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Stretcher Table Ref K884292

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ceiling Mounted Radiographic System Traumex Ref K880530

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pegasus Lateral Cardiac Positioner Ref K915592

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro X-50 Hf Ref K944147

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Csp-A (Ceiling Suspended Positioner-Angio) Ref K924137

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pfm-90 Ceiling Tube Support Ref K900234

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ep-X Biplane Ref K961207

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mammotest Ref K042095

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro-X 15 Hf Ref K912449

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Advantage Ref K883860

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rsx 30HF Ref K930792

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cfx 625 Ref K883976

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Radiographic Film Marketing System Ref K924345

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Genesis 180 Ref K883863

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Comet C-125 Ref K914748

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Three Phase, Diagnostic X-Ray Generator Micro-X 80 Ref K880522

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Rsx-525HF Ref K943504

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ximatron/Ct Option Ref K910647

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Micro-X 30 Hf Ref K914266

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sis 2000 Mammographic X-Ray System Ref K885127

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Elite 5000 Ref K905501

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tangent Iv Ref K912586

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Radiographic Ceiling Tube Support CTS15 Ref K893653

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Mammographic X-Ray System Athena Ref K880531

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Athena Hfx Ref K945619

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 69

Showing 1-50 of 69

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 11 recalls.

  • 2006

    • 27 Mar 2006 Z-0757-06 Unclassified (pre-2012) Terminated Software upgrade to preclude lost images during mammography procedure. Distribution: Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military…
      Full distribution text Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees.
      Submission number: P010017S007

  • 2005

    • 28 Apr 2005 Z-1524-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1525-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1526-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
      Submission numbers: K912448, K934481, K961207
    • 28 Apr 2005 Z-1527-05 Unclassified (pre-2012) Terminated Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient. Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military…
      Full distribution text Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
    • 13 Jan 2005 Z-0713-05 Unclassified (pre-2012) Terminated Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. Distribution: Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United…
      Full distribution text Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
      Submission number: K991293

  • 2004

    • 30 Sep 2004 Z-0787-05 Unclassified (pre-2012) Terminated Some VersaRad Systems have a faulty weld that may result in oil leakage. Distribution: Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA…
      Full distribution text Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
      Submission number: K880530
    • 9 Jul 2004 Z-0379-05 Unclassified (pre-2012) Terminated X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. Distribution: Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to…
      Full distribution text Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.
      Submission number: K861692
    • 21 May 2004 Z-1094-04 Unclassified (pre-2012) Terminated Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. Distribution: FL, NC, NY, OK, WI. Foreign distribution to France. Submission number: P010017
    • 23 Apr 2004 Z-0974-04 Unclassified (pre-2012) Terminated If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury. Distribution: Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada,…
      Full distribution text Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
      Submission number: K880530
Show all 11 recalls

  • 2004

    • 12 Apr 2004 Z-0939-04 Unclassified (pre-2012) Terminated X-ray tube may overheat after high usage because of mis-wired thermal switch circuit. Distribution: Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution. Submission number: P010017

Frequently asked questions

How many devices does Fischer Imaging Corp. have in the registry?

The registry currently lists 69 devices for Fischer Imaging Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fischer Imaging Corp.'s devices?

Among its 50 most recently registered devices, Fischer Imaging Corp. has devices listed in FDA 510(k) (50 devices).

What risk classes do Fischer Imaging Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Fischer Imaging Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Fischer Imaging Corp.?

FDA recall records list 11 recalls initiated by Fischer Imaging Corp., the most recent initiated on 2006-03-27. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Fischer Imaging Corp. in the registry?

The most recently registered devices listed for Fischer Imaging Corp. include RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60, RMS 180, ELITE R 90/15 and FVP-1000 FAMILY AND FVP-1000D FAMILY.

Generated automatically from registry data and not verified by a human reviewer.