Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Multi-purpose diagnostic imaging table FDA UDI
- Device Name
- Relax+ Mobile Examination Table FDA UDI
- Model / Reference
- Relax+ FDA UDI
- Description
- Relax+ Mobile Examination Table FDA UDI
Identifiers
- Catalog Number
- K1018869 FDA UDI
- Primary DI / UDI-DI
- 04049957000714 FDA UDI
- PMA Number
- P840008 FDA UDI
- FDA Product Code
- KQS FDA UDI
- GMDN Term
- Multi-purpose diagnostic imaging table FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Multi-purpose diagnostic imaging table
Dornier MedTech by Dornier MedTech GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose diagnostic imaging table.
- HUT Table — Medical Positioning, Inc. · Class I
- Allegro Imaging Table 120V, 60HZ — Mizuho Orthopedic Systems, Inc. · Class II
- RR HUT Table — Medical Positioning, Inc. · Class I
- UltraScan Versa — Medical Positioning, Inc. · Class I
- EchoBed X — Medical Positioning, Inc. · Class I
- Summit Radiographic table — SUMMIT INDUSTRIES, LLC · Class II
- UltraScan Versa — Medical Positioning, Inc. · Class I
- VACB-3003 — MIZUHO CORPORATION · Class I
Cleared under the same submission
P840008 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dornier MedTech GmbH
Sources (1)
- FDA UDI 039eed76-3f0a-45f9-886c-d9fcdbb03b25 35 fields · synced Jun 8, 2026