DigitalDiagnost C50
K-Number: K163410 · 2017-01-04
Decision Date2017-01-04
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DigitalDiagnost C50 is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under approval number K163410. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DigitalDiagnost C50?
DigitalDiagnost C50 is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K163410.
When was DigitalDiagnost C50 approved by the FDA?
DigitalDiagnost C50 received FDA 510(k) clearance on 2017-01-04, under approval number K163410.
What company makes DigitalDiagnost C50?
DigitalDiagnost C50 is manufactured by Philips Healthcare (Suzhou) Co., Ltd..
What is the FDA product code for DigitalDiagnost C50?
The FDA product code for DigitalDiagnost C50 is KPR.
Other Devices by Philips Healthcare (Suzhou) Co., Ltd.
Related Devices (Code: KPR)
K163203Carestream DRX-EvolutionCarestream Health, Inc.
K163115GC70Samsung Electronics Co., Ltd.
K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.
K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.
K161937CuattroDRCuattro, LLC
K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.