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FDA 510(k)

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

K-Number: K041639 · 2004-09-02

ApplicantEnvisioneering, LLC
Decision Date2004-09-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Envisioneering, LLC. It received FDA 510(k) clearance on 2004-09-02 under 510(k) number K041639. 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 TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM?

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-02. The listed applicant is Envisioneering, LLC. The 510(k) number is K041639.

When did TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM receive FDA 510(k) clearance?

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM received FDA 510(k) clearance on 2004-09-02, under 510(k) number K041639.

Who is the listed applicant for TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM?

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

What is the FDA product code for TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM?

The FDA product code for TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM is IYO.

Related Clinical Trials

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Other records listing Envisioneering, LLC 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.

K073399TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDEK041638TARGETSCAN BIOPSY KITK041637TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

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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