Identity
- Trade Name
- RT CouchTop XD EUDAMEDMR-RT FDA UDI
- Generic Name
- Radiation therapy treatment planning positioning kit FDA UDI
- Device Name
- Ingenia MR-RT hardware EUDAMEDThe Ingenia MR-RT aids the planning of radiation therapy (RT). With the Ingenia MR-RT, you can acquire high-quality MR images in the same patient position as in radiation therapy. MR-RT CouchTop is a dedicated RT patient table replacing the diagnostic tabletop for imaging patients in the RT treatment position. The MR-RT CouchTop is a light, thin flat tabletop to be placed on an MR system. Not suitable for transferring the patient. The RT CouchTop XD is an exchangeable tabletop for Ingenia MR scanners. It is suitable for transferring the patient. FDA UDI
- Model / Reference
- 989603083753 EUDAMEDRT CouchTop XD FDA UDI
- Description
- The Ingenia MR-RT aids the planning of radiation therapy (RT). With the Ingenia MR-RT, you can acquire high-quality MR images in the same patient position as in radiation therapy. MR-RT CouchTop is a dedicated RT patient table replacing the diagnostic tabletop for imaging patients in the RT treatment position. The MR-RT CouchTop is a light, thin flat tabletop to be placed on an MR system. Not suitable for transferring the patient. The RT CouchTop XD is an exchangeable tabletop for Ingenia MR scanners. It is suitable for transferring the patient. FDA UDI
Identifiers
- Catalog Number
- 989603083753 FDA UDI
- Primary DI / UDI-DI
- 00884838112780 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM952TS EUDAMED
- 510(k) Number
- K214081 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Radiation therapy treatment planning positioning kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RT CouchTop XD by Philips Medical Systems Nederland B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM952TS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 432f9382-f4da-4ddb-9d5d-16ed958c8362 61 fields · synced Oct 6, 2026
- FDA UDI abaa9053-9cf4-4e44-961c-c77bbe023f79 36 fields · synced May 29, 2026