Cleared Traditional

K982049 - BIOPSY M

K982049 is an FDA 510(k) clearance for BIOPSY M, manufactured by Sitco, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K982049 · Sitco, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
33d
Days
Class 2
Risk

K982049 is an FDA 510(k) clearance for the BIOPSY M. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Sitco, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on July 14, 1998 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Sitco, Inc. devices

FDA 510(k) Submission Details - K982049

510(k) Number K982049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1998
Decision Date July 14, 1998
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 92
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K982049.
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WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470 · Worldwide Medical Technologies, LLC · Jun 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K980235 · Kci New Technologies, Inc. · Apr 1998
LORAD M-III ELITE (M-III E)
K973631 · Lorad Corp. · Dec 1997