MRCAT Head & Neck
by Philips Oy
510(k) K214081
MRCAT Head & Neck is a Class II device made by Philips Oy, cleared under FDA 510(k) K214081 on 5 Apr 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK214081 | Date5 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K214081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K214081
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MR-RT RT CouchTop XD | 989603083753 / RT CouchTop XD | 00884838112780 | — | On the market |
| MR-RT Rtgo | 300005806303 / Rtgo | 00884838112742 | — | On the market |
| MR-RT RTgo | 300011392021 / RTgo | 00884838122123 | — | On the market |
| MR-RT RTgo 5.0 | 300005806302 / RTgo 5.0 | 00884838107311 | — | No longer on the market |
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