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FDA 510(k)

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)

K-Number: K864519 · 1987-02-13

ApplicantParexel Intl. Corp.
Decision Date1987-02-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1987-02-13 under 510(k) number K864519. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)?

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) is a medical device that received FDA 510(k) clearance on 1987-02-13. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K864519.

When did PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) receive FDA 510(k) clearance?

PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) received FDA 510(k) clearance on 1987-02-13, under 510(k) number K864519.

Who is the listed applicant for PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)?

The FDA 510(k) record lists Parexel Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)?

The FDA product code for PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) is LLZ.

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Other records listing Parexel Intl. Corp. as applicant

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Related Devices (Code: LLZ)

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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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