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FDA 510(k)

X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC

K-Number: K760201 · 1976-10-05

ApplicantAmerican Science and Engineering, Inc.
Decision Date1976-10-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC is the device name listed in this FDA 510(k) record. The listed applicant is American Science and Engineering, Inc.. It received FDA 510(k) clearance on 1976-10-05 under 510(k) number K760201. 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 X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC?

X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC is a medical device that received FDA 510(k) clearance on 1976-10-05. The listed applicant is American Science and Engineering, Inc.. The 510(k) number is K760201.

When did X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC receive FDA 510(k) clearance?

X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC received FDA 510(k) clearance on 1976-10-05, under 510(k) number K760201.

Who is the listed applicant for X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC?

The FDA 510(k) record lists American Science and Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC?

The FDA product code for X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC is JAK.

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Other records listing American Science and Engineering, Inc. 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.

K833237DIGITAL RADIOGRAPHY SYS DUAL GANTRIESK761004X-RAY SCANNER, WHOLE BODY, AS&E

Related Devices (Code: JAK)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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