Cleared Traditional

K934831 - ADVANCED AUTOMATIC KV

K934831 is the FDA 510(k) clearance for ADVANCED AUTOMATIC KV by Elscint, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K934831 · Elscint, Inc. · Radiology device
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Aug 1994
Decision
319d
Days
Class 2
Risk

K934831 is an FDA 510(k) clearance for the ADVANCED AUTOMATIC KV. 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, 1994 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K934831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date August 23, 1994
Days to Decision 319 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
212d slower than avg
Panel avg: 107d · This submission: 319d
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 K934831.
ATHENA HFX
K945619 · Fischer Imaging Corp. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · Elscint, Inc. · Aug 1993
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992