Cleared Traditional

K930282 - AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE...

K930282 is the FDA 510(k) clearance for AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE... by Elscint, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K930282 · Elscint, Inc. · Radiology device
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Aug 1993
Decision
214d
Days
Class 2
Risk

K930282 is an FDA 510(k) clearance for the AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 214 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elscint, Inc. devices

Submission Details

510(k) Number K930282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date August 23, 1993
Days to Decision 214 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
107d slower than avg
Panel avg: 107d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K930282.
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc. · Aug 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992