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FDA 510(k)

S-100 CT SCANNER

K-Number: K780769 · 1978-06-02

ApplicantSyntex Corp.
Decision Date1978-06-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S-100 CT 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 1978-06-02 under 510(k) number K780769. 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 S-100 CT SCANNER?

S-100 CT SCANNER is a medical device that received FDA 510(k) clearance on 1978-06-02. The listed applicant is Syntex Corp.. The 510(k) number is K780769.

When did S-100 CT SCANNER receive FDA 510(k) clearance?

S-100 CT SCANNER received FDA 510(k) clearance on 1978-06-02, under 510(k) number K780769.

Who is the listed applicant for S-100 CT 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 S-100 CT SCANNER?

The FDA product code for S-100 CT SCANNER is JAK.

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Other records listing Syntex Corp. as applicant

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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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