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FDA 510(k)

PREFERENCE MAMMOGRAPHY SYSTEM

K-Number: K945743 · 1995-03-31

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1995-03-31
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PREFERENCE MAMMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1995-03-31 under 510(k) number K945743. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFERENCE MAMMOGRAPHY SYSTEM?

PREFERENCE MAMMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K945743.

When did PREFERENCE MAMMOGRAPHY SYSTEM receive FDA 510(k) clearance?

PREFERENCE MAMMOGRAPHY SYSTEM received FDA 510(k) clearance on 1995-03-31, under 510(k) number K945743.

Who is the listed applicant for PREFERENCE MAMMOGRAPHY SYSTEM?

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

What is the FDA product code for PREFERENCE MAMMOGRAPHY SYSTEM?

The FDA product code for PREFERENCE MAMMOGRAPHY SYSTEM is IZH.

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Related Devices (Code: IZH)

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.

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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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