FDA 510(k)

ProxiDiagnost N90 / Precision CRF (706110, 706400)

K-Number: K233945 · 2024-01-11

ApplicantPhilips Medical Systems Dmc GmbH

Decision Date2024-01-11

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ProxiDiagnost N90 / Precision CRF (706110, 706400) 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 2024-01-11 under 510(k) number K233945. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProxiDiagnost N90 / Precision CRF (706110, 706400)?

ProxiDiagnost N90 / Precision CRF (706110, 706400) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Philips Medical Systems Dmc GmbH. The 510(k) number is K233945.

When did ProxiDiagnost N90 / Precision CRF (706110, 706400) receive FDA 510(k) clearance?

ProxiDiagnost N90 / Precision CRF (706110, 706400) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K233945.

Who is the listed applicant for ProxiDiagnost N90 / Precision CRF (706110, 706400)?

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 ProxiDiagnost N90 / Precision CRF (706110, 706400)?

The FDA product code for ProxiDiagnost N90 / Precision CRF (706110, 706400) is JAA.

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 C K233678Radiography 7000 M K232910CombiDiagnost R90 K212186Philips Radiology Smart Assistant K212837ProxiDiagnost N90 K210692DigitalDiagnost

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.