FDA 510(k)

B-SCAN PLUS

K-Number: K070943 · 2007-04-19

Decision Date2007-04-19

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

B-SCAN PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Accutome Ultrasound, Inc.. It received FDA 510(k) clearance on 2007-04-19 under 510(k) number K070943. 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 B-SCAN PLUS?

B-SCAN PLUS is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Accutome Ultrasound, Inc.. The 510(k) number is K070943.

When did B-SCAN PLUS receive FDA 510(k) clearance?

B-SCAN PLUS received FDA 510(k) clearance on 2007-04-19, under 510(k) number K070943.

Who is the listed applicant for B-SCAN PLUS?

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

What is the FDA product code for B-SCAN PLUS?

The FDA product code for B-SCAN PLUS is IYO.

Other records listing Accutome Ultrasound, 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.

K083377ACCUPEN K042752ACCUPACH V

Related Devices (Code: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow 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.