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FDA 510(k)

ULTRASOUND

K-Number: K771600 · 1977-09-22

ApplicantToshiba Medical Systems
Decision Date1977-09-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1977-09-22 under 510(k) number K771600. 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 ULTRASOUND?

ULTRASOUND is a medical device that received FDA 510(k) clearance on 1977-09-22. The listed applicant is Toshiba Medical Systems. The 510(k) number is K771600.

When did ULTRASOUND receive FDA 510(k) clearance?

ULTRASOUND received FDA 510(k) clearance on 1977-09-22, under 510(k) number K771600.

Who is the listed applicant for ULTRASOUND?

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

What is the FDA product code for ULTRASOUND?

The FDA product code for ULTRASOUND is IYO.

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Related PubMed Literature

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.

PMID: 34499554Focal High-Intensity Focused Ultrasound Ablation of the Prostate.Journal of endourology ()PMID: 32530098Introduction to artificial intelligence in ultrasound imaging in obstetrics and gynecology.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology ()

Other records listing Toshiba Medical Systems 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.

K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954310BLA-800AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA

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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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