ClearanceBrief
510(k) K210692 ยท KPR System, X-Ray, Stationary

DigitalDiagnost

ApplicantPhilips Medical Systems Dmc GmbH, Hamburg, DE
DecisionSubstantially Equivalent, Apr 2, 2021
ReceivedMar 8, 2021
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K210692

DateFirm and productCodeLinked 510(k)
Nov 7, 2025Philips Medical Systems DMC GmbH
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Open, Classified		 KPRNone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Open, Classified		 KPRNone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Open, Classified		 JAANone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Open, Classified		 JAANone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Open, Classified		 JAANone listed
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Open, Classified		 JAANone listed
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Open, Classified		 KPRNone listed
Jul 12, 2022Philips Medical Systems DMC GmbH
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Open, Classified		 KPRNone listed

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