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C-Rad Positioning AB

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C-Rad Positioning AB is a medical device manufacturer, with 38 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIb; FDA Class I and II) and 3 FDA recalls as of 13 Nov 2026.

Devices
38
FDA recalls
32 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 22
  • EUDAMED 20
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class I 14
  • FDA Class I 13
  • EU Class IIb 6
  • FDA Class II 5
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • DUNS 509296997

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What C-Rad Positioning AB makes

C-Rad Positioning AB manufactures laser-based patient positioning systems, including the HIT Laser series and the Catalyst/Catalyst+ devices. These systems are designed for precise alignment and immobilization of patients during medical imaging and radiation therapy procedures, ensuring consistent positioning across multiple sessions.

The company’s devices are classified as Class I and Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated in the United States, where the manufacturer is based.

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

Catalogue38

Newest first, rows 1-38 of 38

Search and filter all 38 devices
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  • HIT Laser HITSDXY Red

    Listed Registry: GUDID Class:I

  • HIT laser HITSDX Green

    Listed Registry: GUDID Class:I

  • HIT Laser HITMX Red

    Listed Registry: GUDID Class:I

  • HIT Laser HITMXY Red

    Listed Registry: GUDID Class:I

  • HIT Laser HITSDX red

    Listed Registry: GUDID Class:I

  • HIT Laser HIT Red

    Listed Registry: GUDID Class:I

  • Catalyst SP002

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

  • HIT Laser HIT Red&Green

    Listed Registry: GUDID Class:I

  • HIT Laser HITSDXY green

    Listed Registry: GUDID Class:I

  • Catalyst+ SP003 Open recall

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

  • HIT Laser HITMXY Red&Green

    Listed Registry: GUDID Class:I

  • HIT Laser HITMXY Green

    Listed Registry: GUDID Class:I

  • HIT Laser HITMX Red&Green

    Listed Registry: GUDID Class:I

  • HIT Laser HIT Green

    Listed Registry: GUDID Class:I

  • Catalyst+ SP003 Open recall

    Active Regimes: CE MDR CE MDD 510(k) Registry: GUDID Class:II

  • HIT Laser HITMX Green

    Listed Registry: GUDID Class:I

  • HIT3 Red Ref SP006-0012

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HITM Green Ref SP006-0021

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Sentinel, Model Sp-001 Ref K082582

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

  • Positioner Ref K063839

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

  • Hitm Ref SP006-0001

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • cAccessory Ref SP-004

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Catalyst+ PT X4 Ref SP003-0009

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • HIT1 Green Ref SP007-0021

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HIT5 Green Ref SP006-0023

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HIT1 Red Ref SP007-0011

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HITSD Green Ref SP005-0002

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HITSD MRI Red Ref SP005-0005

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Catalyst+ HD Ring Gantry Ref SP003-0007

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Sentinel 4DCT Ref SP001-0022

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMEDGUDID Class:IIb

  • HITSD MRI Green Ref SP005-0006

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Catalyst+ PT Ref SP003-0008

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • HITM Red Ref SP006-0011

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HIT5 Red Ref SP006-0013

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Catalyst+ HD Ref SP003-0002 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • Catalyst+ Ref SP003-0001

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • HIT3 Green Ref SP006-0022

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • HIT6 Ref SP006-0004

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-38 of 38

Company details

DUNS number
509296997
Phone
5617429260

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by C-Rad Positioning AB, the earliest on 2020-08-06 and the most recent on 2025-10-09. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: software or firmware. 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.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 2
  • 2026 0

  • 2025

    • 9 Oct 2025 Z-1092-2026 Class II Ongoing Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. Distribution: The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of…
      Full distribution text The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.
      Submission number: K200435
    • 22 Apr 2025 Z-1858-2025 Class II Ongoing Software issue with scanning equipment that can results in the filed rotation not being applied correctly. Distribution: Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.
      Submission number: K200435

  • 2020

    • 6 Aug 2020 Z-2075-2021 Class II Terminated PC Application Software c4D not changing Site upon synchronization during the Setup workflow step Distribution: US Nationwide distribution in the states of IL, KY, MO and WA. Submission number: K113276

Sites1

Frequently asked questions

How many devices does C-Rad Positioning AB have in the registry?

The registry currently lists 38 devices for C-Rad Positioning AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list C-Rad Positioning AB's devices?

Among its 38 most recently registered devices, C-Rad Positioning AB has devices listed in EUDAMED (20 devices), FDA 510(k) (2 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do C-Rad Positioning AB's devices fall under?

Among its 38 most recently registered devices, the classes recorded for C-Rad Positioning AB's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for C-Rad Positioning AB?

FDA recall records list 3 recalls initiated by C-Rad Positioning AB, the most recent initiated on 9 Oct 2025. 2 of them are recorded as ongoing. 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 C-Rad Positioning AB in the registry?

The most recently registered devices listed for C-Rad Positioning AB include HIT Laser HITSDXY Red, HIT laser HITSDX Green, HIT Laser HITMX Red and HIT Laser HITMXY Red.

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