MR-RT RTgo 5.0
by Philips Oy
MR-RT RTgo 5.0 (300005806302) is a Class II device made by Philips Oy, cleared under FDA 510(k) K214081 on 5 Apr 2022 and listed in FDA GUDID since 14 Jun 2022 (UDI-DI 00884838107311), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00884838107311 | Date14 Jun 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK214081 | Date5 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 00884838107311
- FDA 510(k) database K214081
Across registries
- FDA 510(k) K214081 decided 5 Apr 2022 Active
- FDA GUDID UDI-DI 00884838107311 listed 14 Jun 2022 Listed
Timeline
- Cleared FDA 510(k) K214081
- Listed FDA GUDID 00884838107311
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MR-Rt
- Generic name
- MRI system application software
- Model / Ref / Catalog
- RTgo 5.0, 300005806302
- Primary DI / UDI-DI
- 00884838107311
- FDA product code
- MUJ
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- Not in Commercial Distribution
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