Identity
- Trade Name
- Radiography 7000 M EUDAMEDFDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Mobile X-ray Systems EUDAMEDRadiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small) FDA UDI
- Model / Reference
- 712010 EUDAMEDFDA UDI
- Description
- Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838115521 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1129M6 EUDAMED
- FDA Product Code
- IZL FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Radiography 7000 M by Philips Medical Systems DMC GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233678 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM1129M6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (3)
- EUDAMED b8f1d3be-8399-4423-8871-f4c1948f44c4 61 fields · synced Jul 18, 2026
- FDA UDI 06a112bc-89cc-49cb-9c7e-3d7d5a15d663 33 fields · synced May 30, 2026
- FDA 510(k) K233678 1 fields · synced May 18, 2026