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Imaging Sciences Intl., Inc.

United StatesFDA applicant, unverified

Devices
7
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Imaging Sciences Intl., Inc. makes

Imaging Sciences Intl., Inc. manufactures computed tomography (CT) scanners, including multi-slice and cone-beam models such as the MULTI-PULSE 2000, I-CAT SCANNER, and 2000 X-RAY - TOMOGRAPHIC. Their portfolio also includes specialized imaging systems like the DVT SCANNER for deep vein thrombosis detection and the PANATOME for panoramic dental imaging. Surgical planning tools, such as SURGPLAN and PANPLAN, are designed for pre-operative assessment and treatment planning.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s products are authorized for use in the United States, where the manufacturer is based.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

  • Multi-Pulse 2000 Ref K001248

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

  • Xr-910 Ref K981466

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

  • Dvt Scanner Ref K051980

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

  • Panatome Ref K991518

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

  • I-Cat Scanner Ref K061284

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

  • 2000 X-Ray - Tomographic Ref K931815

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

  • Surgplan And Panplan Ref K041078

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

FDA recalls2

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

FDA recall records list 2 recalls initiated by Imaging Sciences Intl., Inc., initiated on 2008-03-19. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2008

    • 19 Mar 2008 Z-1645-2008 Unclassified (pre-2012) Terminated incorrect scatter labeling Distribution: The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada,…
      Full distribution text The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.
      Submission number: K051980
    • 19 Mar 2008 Z-1646-2008 Unclassified (pre-2012) Terminated Incorrect scatter information in the manual. Distribution: The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada,…
      Full distribution text The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.
      Submission number: K061284

Frequently asked questions

How many devices does Imaging Sciences Intl., Inc. have in the registry?

The registry currently lists 7 devices for Imaging Sciences Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Imaging Sciences Intl., Inc.'s devices?

Among its 7 most recently registered devices, Imaging Sciences Intl., Inc. has devices listed in FDA 510(k) (7 devices).

What risk classes do Imaging Sciences Intl., Inc.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Imaging Sciences Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Imaging Sciences Intl., Inc.?

FDA recall records list 2 recalls initiated by Imaging Sciences Intl., Inc., the most recent initiated on 19 Mar 2008. 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 Imaging Sciences Intl., Inc. in the registry?

The most recently registered devices listed for Imaging Sciences Intl., Inc. include MULTI-PULSE 2000, XR-910, DVT SCANNER and PANATOME.

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