Cleared Traditional

K041638 - TARGETSCAN BIOPSY KIT

K041638 is an FDA 510(k) clearance for TARGETSCAN BIOPSY KIT, 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 77-day FDA review.

K041638 · Envisioneering, LLC · Radiology device
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Sep 2004
Decision
77d
Days
Class 2
Risk

K041638 is an FDA 510(k) clearance for the TARGETSCAN BIOPSY KIT. 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 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 892.1570 - 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.

View all Envisioneering, LLC devices

FDA 510(k) Submission Details - K041638

510(k) Number K041638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
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
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.

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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 288
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