Cleared Traditional

K896596 - ALPHA III PLUS AND MODEL P2500F/101 W/O...

K896596 is an FDA 510(k) clearance for ALPHA III PLUS AND MODEL P2500F/101 W/O..., manufactured by Instrumentarium Imaging, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 555-day FDA review.

K896596 · Instrumentarium Imaging, Inc. · Radiology device
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May 1991
Decision
555d
Days
Class 2
Risk

K896596 is an FDA 510(k) clearance for the ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Instrumentarium Imaging, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 555 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 Instrumentarium Imaging, Inc. devices

FDA 510(k) Submission Details - K896596

510(k) Number K896596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date May 30, 1991
Days to Decision 555 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
448d slower than avg
Panel avg: 107d · This submission: 555d
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 60
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K896596.
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
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VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS
K910111 · Instrumentarium Imaging, Inc. · Sep 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974 · Elscint, Inc. · Sep 1991
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · Fischer Imaging Corp. · Mar 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · Philips Medical Systems North America, Inc. · Jan 1990
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989