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FDA 510(k)

A-SCAN PLUS CONNECT

K-Number: K123349 · 2013-01-29

ApplicantAccutome, Inc.
Decision Date2013-01-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A-SCAN PLUS CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Accutome, Inc.. It received FDA 510(k) clearance on 2013-01-29 under 510(k) number K123349. 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 A-SCAN PLUS CONNECT?

A-SCAN PLUS CONNECT is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Accutome, Inc.. The 510(k) number is K123349.

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

A-SCAN PLUS CONNECT received FDA 510(k) clearance on 2013-01-29, under 510(k) number K123349.

Who is the listed applicant for A-SCAN PLUS CONNECT?

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

What is the FDA product code for A-SCAN PLUS CONNECT?

The FDA product code for A-SCAN PLUS CONNECT 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.

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Other records listing Accutome, 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.

K103471UBM PLUSK050552PACHPEN PACHYMETER, MODEL 24-5100K032956ACCUSONIC A-SCAN MODEL, 24-4000K820050KREMER BLADE GAUGEK810660KREMER CORNEOMETER ULTRASONIC PACHOMETER

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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