Chrysalis Intelligence · Sponsors · C-Rad Positioning AB

C-Rad Positioning AB

Uppsala, SE · 2 510(k) clearances · 3 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
2
2020-04-20 → 2020-05-07
Last 12 months
0
Product codes
1
Most recent
2020-05-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYE — — — 2 2020-05-07
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
2
Most recent
2025-10-09
DateSeverityStatusRecall # ProductCodeReason
2025-10-09 Class II Ongoing Z-1092-2026 Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version… — 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 syst…
2025-04-22 Class II Ongoing Z-1858-2025 Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (… — Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
2020-08-06 Class II Terminated 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
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2020-05-07 K200435 Catalyst+, Catalyst+ HD IYE — —
2020-04-20 K200600 Sentinel IYE — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence