Cleared Traditional

K041637 - TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

K041637 is an FDA 510(k) clearance for TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM, manufactured by Envisioneering, LLC. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K041637 · 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
76d
Days
Class 2
Risk

K041637 is an FDA 510(k) clearance for the TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Envisioneering, LLC (St. Louis, US). The FDA issued a Cleared decision on September 1, 2004 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 - K041637

510(k) Number K041637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date September 01, 2004
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 412
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K041637.
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
K042445 · Bard Access Systems, Inc. · Oct 2004
MHLX7EC TRANSDUCER
K040213 · Microhelix, Inc. · Sep 2004
TARGETSCAN BIOPSY KIT
K041638 · Envisioneering, LLC · Sep 2004
EG-3630UR
K041395 · Pentax Precision Instrument Corp. · Jun 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K041396 · Pentax Precision Instrument Corp. · Jun 2004
EG-3830UT
K041397 · Pentax Precision Instrument Corp. · Jun 2004
K041637 · TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
Download PDF FDA Summary Envisioneering, LLC