Catalyst+, Catalyst+ HD
FDA 510(k) clearance K200435 · decided 2020-05-07
Clearance details
- K-number
- K200435
- Device name
- Catalyst+, Catalyst+ HD
- Applicant
- C-Rad Positioning AB
- Decision
- Substantially Equivalent
- Date received
- 2020-02-24
- Decision date
- 2020-05-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, recall (Z-1092-2026) | C-RAD POSITIONING AB | 2026-01-14 |
| Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001- recall (Z-1858-2025) | C-RAD POSITIONING AB | 2025-05-28 |