Data / Medical devices / Sweden / C-Rad Positioning AB
C-Rad Positioning AB: FDA-registered device maker in Uppsala, Sweden, 4 510(k) clearances
C-Rad Positioning AB is registered with the FDA (registration 3006621300) in Uppsala, Sweden. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 7, 2020. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006621300
- Address
- Sjukhusvagen 12K, Uppsala, Sweden, 75309
- Owner or operator
- C-RAD Positioning AB (9096047)
- Roles
- Manufacturer
- First device listed
- March 26, 2012
- Registered through
- 2026
- Brand names listed
- CYRPA HIT1, HIT3, HIT5, HIT6, HITM, HITSD, SMARTPHANTOM CT, SMARTPHANTOM RT, STATICPHANTOM, Catalyst, Catalyst HD, Catalyst+, Catalyst+ HD, Catalyst+ HD Ring Gantry, Catalyst+ LITE, Catalyst+ PT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2020 | K200435 | Catalyst+, Catalyst+ HD | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| April 20, 2020 | K200600 | Sentinel | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| July 30, 2012 | K120668 | SENTINEL | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| February 27, 2012 | K113276 | CATALYST | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | 97872 | Class II | Ongoing | Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning d | 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. | accessdata.fda.gov |
| April 22, 2025 | 96791 | Class II | Ongoing | Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0 | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. | accessdata.fda.gov |
| August 6, 2020 | 88084 | Class II | Terminated | PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 | PC Application Software c4D not changing Site upon synchronization during the Setup workflow step | accessdata.fda.gov |
Compare with other makers
Updated January 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.