Catalyst+, Catalyst+ HD— 510(k) K200435
Substantially EquivalentC-Rad Positioning AB
FDA 510(k) clearance K200435 for Catalyst+, Catalyst+ HD, Substantially Equivalent on 2020-05-07. Applicant: C-Rad Positioning AB. Device class: 2.
Clearance details
- Applicant
- C-Rad Positioning AB
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code IYE
view allMore clearances from C-Rad Positioning AB
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200435
K-number listed on FDA's recall record- 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
- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200435.
Data sourced from openFDA. This site is unofficial and independent of the FDA.