510(k) K200435 ยท IYE Accelerator, Linear, Medical
Catalyst+, Catalyst+ HD
| Applicant | C-Rad Positioning AB, Uppsala, SE |
| Decision | Substantially Equivalent, May 7, 2020 |
| Received | Feb 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2026 | C-RAD POSITIONING AB 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 P Open, Classified |
IYE | None listed |
| May 28, 2025 | C-RAD POSITIONING AB 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+ (SP003-0 Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.