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.…
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)
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), Guangdong (1).
Record
Regulatory record for Radiography 7000 M | Listed by | Philips Medical Systems DMC GmbH, Germany |
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-02-22 |
| Record revised | 2026-05-22 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -10 to 40 °C; Storage environment humidity 20 to 85 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.