Cleared Traditional

K041639 - TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

K041639 is an FDA 510(k) clearance for TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM, manufactured by Envisioneering, LLC. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K041639 · Envisioneering, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
77d
Days
Class 2
Risk

K041639 is an FDA 510(k) clearance for the TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Envisioneering, LLC (St. Louis, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041639

510(k) Number K041639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date September 02, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
SILVIA ANKOVA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 869
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K041639.
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
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K042540 · Philips Ultrasound, Inc. · Oct 2004
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
K041947 · Innovative Imaging, Inc. · Aug 2004
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K041455 · Sonoscape Company Limited · Jun 2004
VUE 100 ULTRASOUND IMAGING SYSTEM
K040652 · Mobilsonic, Inc. · May 2004
K041639 · TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
Download PDF FDA Summary Envisioneering, LLC