Targetscn Transrectal Ultrasound System

Q: What is the product code of K041639?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.

FDA 510(k) K041639 · Envisioneering, LLC

Substantially Equivalent

510(k) numberK041639

Submission

Device name: Targetscn Transrectal Ultrasound System
Applicant: Envisioneering, LLC
St. Louis, MO, US
Received: June 17, 2004
Decision date: September 2, 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: IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1560
Specialty: Radiology

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K243227	B-ScanIYO · Traditional	Accutome, Inc. Doing Business AS Keeler USA	07/11/2025SE

More from Accutome, Inc. Doing Business AS Keeler USA

510(k)	Device	Decision
K073399	Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideFCG · Special	12/21/2007SE
K041638	Targetscan Biopsy KitITX · Traditional	09/02/2004SESK
K041637	Targetscan Transrectal Ultrasound SystemITX · Traditional	09/01/2004SE

Questions and answers

When was Targetscn Transrectal Ultrasound System cleared by the FDA?

Targetscn Transrectal Ultrasound System (K041639) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 77 days after the submission was received.

What is the product code of K041639?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.