ClearanceBrief
510(k) K202564 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

DigitalDiagnost C90

ApplicantPhilips Medical Systems Dmc GmbH, Hamburg, DE
DecisionSubstantially Equivalent, Sep 30, 2020
ReceivedSep 4, 2020
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K202564

DateFirm and productCodeLinked 510(k)
Jun 5, 2026Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Open, Classified
MQBNone listed
Nov 7, 2025Philips Medical Systems DMC GmbH
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Open, Classified
MQBNone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAANone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAANone listed
Jun 30, 2023Philips North America Llc
DigitalDiagnost C90, Model No. 712034 and 712035
Open, Classified
MQBNone listed
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Open, Classified
KPRNone listed
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Open, Classified
KPRNone listed
Sep 22, 2021Philips Healthcare
DigitalDiagnost C90
Open, Classified
MQBNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.