Cleared Traditional

K925961 - OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM

K925961 is an FDA 510(k) clearance for OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM, manufactured by Diagnostic Archives, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K925961 · Diagnostic Archives, Inc. · Radiology device
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Mar 1993
Decision
97d
Days
Class 2
Risk

K925961 is an FDA 510(k) clearance for the OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Diagnostic Archives, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on March 2, 1993 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Diagnostic Archives, Inc. devices

FDA 510(k) Submission Details - K925961

510(k) Number K925961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date March 02, 1993
Days to Decision 97 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
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 167
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K925961.
MULTI-VIEW PROCESSOR (MVP)
K931184 · Adac Laboratories · Nov 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993
DLX
K926258 · GE Medical Systems · Mar 1993
ANCOR
K924719 · Siemens Medical Solutions USA, Inc. · Dec 1992
CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT
K926082 · Biodan Medical Systems, Ltd. · Dec 1992
CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
K924137 · Fischer Imaging Corp. · Dec 1992