Identity
- Trade Name
- Duet DRF FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Model / Reference
- 63111976 FDA UDI
Identifiers
- Catalog Number
- 63640509 FDA UDI
- Primary DI / UDI-DI
- 07290012104701 FDA UDI
- 510(k) Number
- K103038 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
No
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
Category: Stationary general-purpose fluoroscopic x-ray system, digital
Duet DRF by C.m.t. Medical Technologies Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.
- CANON INC. — CANON INC. · Class II
- FLUOROspeed — Shimadzu Corp. · Class II
- NAUTILUS — TECHNIX SPA · Class II
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA · Class II
- SONIALVISION G4 — Shimadzu Corp. · Class II
- Duet DRF — THALES AVS FRANCE SAS · Class II
- STEPHANIX — Stephanix · Class II
- STEPHANIX — Stephanix · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C.m.t. Medical Technologies Ltd.
Sources (1)
- FDA UDI 6f4e8a3e-91fd-4b5e-9642-41e162c6ff6d 34 fields · synced May 30, 2026