C-Rad Positioning AB
Uppsala, SE
C-RAD POSITIONING AB appears in FDA device records in Uppsala, SE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for C-Rad Positioning AB between 2007 and 2020. The busiest year on record is 2012, with 2. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2012 | 2 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200435 | Catalyst+, Catalyst+ HD | IYE | Substantially Equivalent | |
| K200600 | Sentinel | IYE | Substantially Equivalent | |
| K120668 | SENTINEL | IYE | Substantially Equivalent | |
| K113276 | CATALYST | IYE | Substantially Equivalent | |
| K082582 | SENTINEL, MODEL SP-001 | IYE | Substantially Equivalent | |
| K063839 | POSITIONER | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006621300 | 3006621300 | C-RAD POSITIONING AB | Sjukhusvagen 12K, UPPSALA 75309 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1092-2026 | 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 device, diagnostic imaging/radiotherapy, laser Component: Not applicable | 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. | Class II | Open, Classified | |
| Z-1858-2025 | 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 (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. | Class II | Open, Classified | |
| Z-2075-2021 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain