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FDA 510(k)

TOMOGRAPHIC SYSTEM, COMPUTERIZED

K-Number: K772123 · 1977-11-21

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1977-11-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMOGRAPHIC SYSTEM, COMPUTERIZED 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 1977-11-21 under 510(k) number K772123. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMOGRAPHIC SYSTEM, COMPUTERIZED?

TOMOGRAPHIC SYSTEM, COMPUTERIZED is a medical device that received FDA 510(k) clearance on 1977-11-21. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K772123.

When did TOMOGRAPHIC SYSTEM, COMPUTERIZED receive FDA 510(k) clearance?

TOMOGRAPHIC SYSTEM, COMPUTERIZED received FDA 510(k) clearance on 1977-11-21, under 510(k) number K772123.

Who is the listed applicant for TOMOGRAPHIC SYSTEM, COMPUTERIZED?

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 TOMOGRAPHIC SYSTEM, COMPUTERIZED?

The FDA product code for TOMOGRAPHIC SYSTEM, COMPUTERIZED is JAK.

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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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