Raypilot Software 1
Raypilot Software 1 (3004) is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Micropos Medical AB (Publ), cleared under FDA 510(k) K203722 on 2 Sep 2021 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 07350007953049), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350007953049 | Date4 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203722 | Date2 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 07350007953049
- FDA 510(k) database K203722
Across registries
- FDA 510(k) K203722 decided 2 Sep 2021 Active
- FDA GUDID UDI-DI 07350007953049 listed 4 Apr 2023 Listed
Timeline
- Cleared FDA 510(k) K203722
- Listed FDA GUDID 07350007953049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Raypilot Software
- Generic name
- Radiation therapy invasive marker lesion localization system
- Model / Ref / Catalog
- 1, 3004
- Primary DI / UDI-DI
- 07350007953049
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiation therapy invasive marker lesion localization system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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