DigitalDiagnost C90— 510(k) K202564
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K202564 for DigitalDiagnost C90, Substantially Equivalent on 2020-09-30. Applicant: Philips Medical Systems Dmc GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Dmc GmbH
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hamburg, DE
Recent devices under product code MQB
view allMore clearances from Philips Medical Systems Dmc GmbH
view allRecalls naming K202564
K-number listed on FDA's recall record- Z-2354-2026 — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
- Z-0465-2026 — DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
- Z-0275-2024 — DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
- Z-0276-2024 — DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
- Z-2042-2023 — DigitalDiagnost C90, Model No. 712034 and 712035
- Z-0239-2022 — DigitalDiagnost C90
- Z-1328-2022 — DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
- Z-1329-2022 — DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202564.
Data sourced from openFDA. This site is unofficial and independent of the FDA.