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FDA 510(k)

X-RAY SCANNER, WHOLE BODY, AS&E

K-Number: K761004 · 1976-12-16

ApplicantAmerican Science and Engineering, Inc.
Decision Date1976-12-16
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY SCANNER, WHOLE BODY, AS&E 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 1976-12-16 under 510(k) number K761004. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY SCANNER, WHOLE BODY, AS&E?

X-RAY SCANNER, WHOLE BODY, AS&E is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is American Science and Engineering, Inc.. The 510(k) number is K761004.

When did X-RAY SCANNER, WHOLE BODY, AS&E receive FDA 510(k) clearance?

X-RAY SCANNER, WHOLE BODY, AS&E received FDA 510(k) clearance on 1976-12-16, under 510(k) number K761004.

Who is the listed applicant for X-RAY SCANNER, WHOLE BODY, AS&E?

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, WHOLE BODY, AS&E?

The FDA product code for X-RAY SCANNER, WHOLE BODY, AS&E is IZF.

Related Clinical Trials

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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 GANTRIESK760201X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC

Related Devices (Code: IZF)

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.

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix LimitedK250850Nanox.ARC XNano-X Imaging , Ltd.K242395Nanox.ARCNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH

Official Source

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