ArtPix DRF
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- ArtPix DRF EUDAMEDFDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- Dynamic imaging solutions EUDAMEDArtPix DRF EUDAMED
- Model / Reference
- 63627589 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290012104909 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290012104016W EUDAMEDB-07290012104909 EUDAMED
- Direct Marketing DI
- 07290012104909 EUDAMED
- 510(k) Number
- K202235 FDA UDI
- FDA Product Code
- JAA FDA UDIMQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Stationary basic diagnostic x-ray system, digital
ArtPix DRF is a dynamic imaging solution device classified as Class IIb, designed for radiology applications. It is a non-implantable, non-sterile device that is not reusable and does not administer medicine or contain human or animal tissues.
The device is supplied by CMT Medical Technologies, Ltd. and has received FDA 510(k) clearance with product code JAA. It is not MRI compatible and is stored according to standard device criteria. The device has been authorized under FDA 510(k), MDD, and MDR regulations.
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Frequently asked questions
What is the ArtPix DRF device used for?
ArtPix DRF is a dynamic imaging solution device designed specifically for radiology applications. It is a non-implantable, non-sterile device that does not administer medicine or contain human or animal tissues.
How is the ArtPix DRF supplied and what are its sterility characteristics?
The ArtPix DRF is supplied by CMT Medical Technologies, Ltd. It is a non-sterile device that is not reusable, meaning it is designed for single-use only and should not be reprocessed or used on multiple patients.
What regulatory approvals does the ArtPix DRF have?
The ArtPix DRF has received FDA 510(k) clearance with product code JAA. It is also authorized under MDD and MDR regulations, indicating it meets the necessary requirements for medical device registration in those jurisdictions.
Is the ArtPix DRF MRI compatible and how should it be stored?
The ArtPix DRF is not MRI compatible. It should be stored according to standard device criteria, though specific storage conditions are not detailed in the available information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K202235 FDA 510(k) - ArtPIX DRF | Cmt Medical Technologies, Ltd., PDF CMT Medical Technologies, Ltd. September 3, 2020 Dror Wertman Director ..., Cmt Medical Technologies, Ltd. - FDA 510 (k) Cleared Devices, 510 (k) K202235 — ArtPIX DRF — RegDataLab, ArtPIX DRF 510 (k) K202235 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7290012104016W | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202235 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7290012104016W | Class IIb | Active |
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Manufacturer
- Manufacturer
- CMT Medical Technologies, Ltd.
- EUDAMED SRN
- IL-MF-000017569
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 0e12027d-997f-4623-8dce-02dbeb3a6faa 85 fields · synced Sep 21, 2026
- FDA UDI b8bac88d-f280-4dd8-a06c-35929f530437 33 fields · synced May 30, 2026
- EUDAMED 724d19d2-ffa3-4dac-9f6e-02f0e88d0dda 61 fields · synced Jul 15, 2026
- FDA 510(k) K202235 1 fields · synced May 18, 2026