510(k) K202564 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DigitalDiagnost C90
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Sep 30, 2020 |
| Received | Sep 4, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202564
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | Philips North America Llc DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. Open, Classified |
MQB | None listed |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER;
Model Number: (1) 712034, (2) 712035; Open, Classified |
MQB | None listed |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | None listed |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | None listed |
| Jun 30, 2023 | Philips North America Llc DigitalDiagnost C90, Model No. 712034 and 712035 Open, Classified |
MQB | None listed |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 High Performance. radiography and fluoroscopy system Open, Classified |
KPR | None listed |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system Open, Classified |
KPR | None listed |
| Sep 22, 2021 | Philips Healthcare DigitalDiagnost C90 Open, Classified |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.