Identity
- Trade Name
- Qfix® MRI Pelvis System FDA UDI
- Generic Name
- Radiological pelvis positioner FDA UDI
- Device Name
- Qfix MRI Pelvis System Includes Knee Wedge and set of 6" Opti-Handles FDA UDI
- Model / Reference
- RT-4526SMRI FDA UDI
- Description
- Qfix MRI Pelvis System Includes Knee Wedge and set of 6" Opti-Handles FDA UDI
Identifiers
- Catalog Number
- RT-4526SMRI FDA UDI
- Primary DI / UDI-DI
- 10841962108635 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological pelvis positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
MR Safe FDA UDI
Category: Radiological pelvis positioner
Qfix® MRI Pelvis System by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological pelvis positioner.
- Positioning Cushion — Medtec LLC · Class II
- HipFix® Baseplate — Medtec LLC · Class II
- Back/Abdomen SatPad™ — Sat Pad Inc. · Class II
- Belly Board MRI — Medtec LLC · Class II
- Prone Thorax Support Cushion — Medtec LLC · Class II
- Groin Piece — Medtec LLC · Class II
- MEDRAD® PRO-TEKT Endorectal Balloon — Bayer Medical Care Inc. · Class I
- Belly Board Flat Cushion — Medtec LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (1)
- FDA UDI 154e0542-90ba-4a0d-9795-f3d745d04d95 35 fields · synced May 30, 2026