Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

pixium 4343RCE

K-Number: K170113 · 2017-02-09

ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2017-02-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

pixium 4343RCE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K170113. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pixium 4343RCE?

pixium 4343RCE is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Philips Medical Systems Dmc GmbH. The 510(k) number is K170113.

When did pixium 4343RCE receive FDA 510(k) clearance?

pixium 4343RCE received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170113.

Who is the listed applicant for pixium 4343RCE?

The FDA 510(k) record lists Philips Medical Systems Dmc GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pixium 4343RCE?

The FDA product code for pixium 4343RCE is MQB.

Other records listing Philips Medical Systems Dmc GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233662Radiography 7300 CK233678Radiography 7000 MK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)K232910CombiDiagnost R90K212186Philips Radiology Smart AssistantK212837ProxiDiagnost N90

View all 14 devices →

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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.

↑