Cleared Traditional

K932356 - NOVA XM2

K932356 is an FDA 510(k) clearance for NOVA XM2, manufactured by Dynarad Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 636-day FDA review.

K932356 · Dynarad Corp. · Radiology device
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Feb 1995
Decision
636d
Days
Class 2
Risk

K932356 is an FDA 510(k) clearance for the NOVA XM2. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 636 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Dynarad Corp. devices

FDA 510(k) Submission Details - K932356

510(k) Number K932356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date February 08, 1995
Days to Decision 636 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
529d slower than avg
Panel avg: 107d · This submission: 636d
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 88
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K932356.
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · Elscint, Inc. · Mar 1995
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · Philips Medical Systems (Cleveland), Inc. · Mar 1995
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
ALPHA STEREO
K934478 · Instrumentarium Corp. · Jan 1995
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994