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FDA 510(k)

SCANNER 700

K-Number: K812588 · 1981-10-19

ApplicantNational Ultrasound Corp.
Decision Date1981-10-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANNER 700 is the device name listed in this FDA 510(k) record. The listed applicant is National Ultrasound Corp.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812588. 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 SCANNER 700?

SCANNER 700 is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is National Ultrasound Corp.. The 510(k) number is K812588.

When did SCANNER 700 receive FDA 510(k) clearance?

SCANNER 700 received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812588.

Who is the listed applicant for SCANNER 700?

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

What is the FDA product code for SCANNER 700?

The FDA product code for SCANNER 700 is IYO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing National Ultrasound 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.

K802484SINVISION 2001 ULTRASOUND SCANNER

Related Devices (Code: IYO)

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.

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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