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FDA 510(k)

TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

K-Number: K041637 · 2004-09-01

ApplicantEnvisioneering, LLC
Decision Date2004-09-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TARGETSCAN 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 2004-09-01 under 510(k) number K041637. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM?

TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-01. The listed applicant is Envisioneering, LLC. The 510(k) number is K041637.

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

TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM received FDA 510(k) clearance on 2004-09-01, under 510(k) number K041637.

Who is the listed applicant for TARGETSCAN 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 TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM?

The FDA product code for TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM is ITX.

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 KITK041639TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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