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FDA 510(k)

HIGH RESOLUTION IMAGING SYSTEM

K-Number: K792638 · 1980-01-28

ApplicantUnirad Corp.
Decision Date1980-01-28
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIGH RESOLUTION IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Unirad Corp.. It received FDA 510(k) clearance on 1980-01-28 under 510(k) number K792638. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH RESOLUTION IMAGING SYSTEM?

HIGH RESOLUTION IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1980-01-28. The listed applicant is Unirad Corp.. The 510(k) number is K792638.

When did HIGH RESOLUTION IMAGING SYSTEM receive FDA 510(k) clearance?

HIGH RESOLUTION IMAGING SYSTEM received FDA 510(k) clearance on 1980-01-28, under 510(k) number K792638.

Who is the listed applicant for HIGH RESOLUTION IMAGING SYSTEM?

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

What is the FDA product code for HIGH RESOLUTION IMAGING SYSTEM?

The FDA product code for HIGH RESOLUTION IMAGING SYSTEM is IYO.

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Other records listing Unirad 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.

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Related Devices (Code: IYO)

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K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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