Prelude V1. IORT
by MedCom Gesellschaft für medizinische Bildverarbeitung mbH
Prelude V1. IORT is a Class II device made by MedCom Gesellschaft für medizinische Bildverarbeitung mbH, cleared under FDA 510(k) K180308 on 27 Mar 2018 and listed in FDA GUDID since 5 Oct 2022 (UDI-DI 04260308110092), 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 | Number04260308110092 | Date5 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180308 | Date27 Mar 2018 | StatusActive |
Official records
- AccessGUDID record 04260308110092
- FDA 510(k) database K180308
Across registries
- FDA 510(k) K180308 decided 27 Mar 2018 Active
- FDA GUDID UDI-DI 04260308110092 listed 5 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K180308
- Listed FDA GUDID 04260308110092
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Prelude
- Generic name
- Radiation therapy software
- Model / reference
- V1. IORT
- Primary DI / UDI-DI
- 04260308110092
- 510(k) Number
- FDA product code
- MUJ, LHO
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050, 892.1940
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiation therapy software.
- Standard Imaging LinacView Software 91330 by STANDARD IMAGING INC.
- Standard Imaging Adaptivo v1 91350 by STANDARD IMAGING INC.
- FilmQA Pro 8.0 987957 by Ashland Specialty Ingredients, G.P.
- Vitesse 5.0 by Varian Medical Systems, Inc.
- FilmQA Pro 7.0 N/A by Ashland Specialty Ingredients, G.P.
- VERIQA software S070031 by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH