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FDA 510(k)

PHILIPS PIXIUM 4343RC

K-Number: K131483 · 2013-10-07

ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2013-10-07
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS PIXIUM 4343RC 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 2013-10-07 under 510(k) number K131483. 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 PHILIPS PIXIUM 4343RC?

PHILIPS PIXIUM 4343RC is a medical device that received FDA 510(k) clearance on 2013-10-07. The listed applicant is Philips Medical Systems Dmc GmbH. The 510(k) number is K131483.

When did PHILIPS PIXIUM 4343RC receive FDA 510(k) clearance?

PHILIPS PIXIUM 4343RC received FDA 510(k) clearance on 2013-10-07, under 510(k) number K131483.

Who is the listed applicant for PHILIPS PIXIUM 4343RC?

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 PHILIPS PIXIUM 4343RC?

The FDA product code for PHILIPS PIXIUM 4343RC is MQB.

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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

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Related Devices (Code: MQB)

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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.

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