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FDA 510(k)

COMPUTERIZED TOMOGRAPHY SCANNER

K-Number: K761033 · 1976-11-24

ApplicantSyntex Corp.
Decision Date1976-11-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED TOMOGRAPHY SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1976-11-24 under 510(k) number K761033. 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 COMPUTERIZED TOMOGRAPHY SCANNER?

COMPUTERIZED TOMOGRAPHY SCANNER is a medical device that received FDA 510(k) clearance on 1976-11-24. The listed applicant is Syntex Corp.. The 510(k) number is K761033.

When did COMPUTERIZED TOMOGRAPHY SCANNER receive FDA 510(k) clearance?

COMPUTERIZED TOMOGRAPHY SCANNER received FDA 510(k) clearance on 1976-11-24, under 510(k) number K761033.

Who is the listed applicant for COMPUTERIZED TOMOGRAPHY SCANNER?

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

What is the FDA product code for COMPUTERIZED TOMOGRAPHY SCANNER?

The FDA product code for COMPUTERIZED TOMOGRAPHY SCANNER is JAK.

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Other records listing Syntex Corp. 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.

K920314TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K843593SURGIPRESS SURGICAL LOOPK780997AMALGAM ALLOYK780769S-100 CT SCANNERK780483FIBER OPTIC HANDPIECEK761331OPUS I OPTION - FIBER OPTIC L SYSTEM

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Related Devices (Code: 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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