Identity
- Trade Name
- Artis Q.zen biplane FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Model / Reference
- 10848355 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869010038 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDIIZI FDA UDIJAK FDA UDI
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI892.1600 FDA UDI892.1750 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
No
FDA UDI
Category: Stationary angiographic x-ray system, digital
Artis Q.zen biplane by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary angiographic x-ray system, digital.
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- Trinias — Shimadzu Corp. · Class II
- Allura Xper FD — Philips Medical Systems Nederland B.V. · Class II
- Allura Xper FD — Philips Medical Systems Nederland B.V. · Class II
- Trinias — Shimadzu Corp. · Class II
- Allura Xper FD — Philips Medical Systems Nederland B.V. · Class II
- Trinias — Shimadzu Corp. · Class II
- Trinias — Shimadzu Corp. · Class II
Cleared under the same submission
K123529 also covers:
K181407 also covers:
- Artis Q biplane — Siemens Healthcare
- Artis Q ceiling — Siemens Healthcare
- Artis Q.zen ceiling — Siemens Healthcare
- Artis Q.zen floor — Siemens Healthcare
- Artis zee biplane — Siemens Healthcare
- Artis zee ceiling — Siemens Healthcare
- Artis zee floor — Siemens Healthcare
- Artis zee multi-purpose — Siemens Healthcare
- Artis zeego — Siemens Healthcare
- Artis zeego — Siemens Healthcare
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
- Siemens Healthcare
Sources (1)
- FDA UDI fc04a28f-1421-4a2c-a676-5f43b42aef14 35 fields · synced May 31, 2026