Targetscan Transrectal Ultrasound System

Q: What is the product code of K041637?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.

FDA 510(k) K041637 · Envisioneering, LLC

Substantially Equivalent

510(k) numberK041637

Submission

Device name: Targetscan Transrectal Ultrasound System
Applicant: Envisioneering, LLC
St. Louis, MO, US
Received: June 17, 2004
Decision date: September 1, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: ITX – Transducer, Ultrasonic, Diagnostic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1570
Specialty: Radiology

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K260161	SmartGuide Disposable Guides and GridsITX · Traditional	UC-CARE , Ltd.	07/30/2026SE
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K250762	Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional	Olympus Medical Systems Corporation	07/11/2025SE
K250524	Mendaera Guidance SystemITX · Traditional	Mendaera, Inc.	07/02/2025SE
K250469	Accuro® 3S Needle Guide KitITX · Traditional	Rivanna Medical, Inc.	06/13/2025SE
K241662	Ultrasound Transducer CoverITX · Traditional	Vitrolife Sweden AB	08/30/2024SE

More from Vitrolife Sweden AB

510(k)	Device	Decision
K073399	Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideFCG · Special	12/21/2007SE
K041639	Targetscn Transrectal Ultrasound SystemIYO · Traditional	09/02/2004SE
K041638	Targetscan Biopsy KitITX · Traditional	09/02/2004SESK

Questions and answers

When was Targetscan Transrectal Ultrasound System cleared by the FDA?

Targetscan Transrectal Ultrasound System (K041637) received a 510(k) decision of Substantially Equivalent on September 1, 2004, 76 days after the submission was received.

What is the product code of K041637?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.