Cleared Traditional

K931170 - SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)

K931170 is an FDA 510(k) clearance for SONY CARDIAC ANALYSIS AND REVIEW STATIO..., manufactured by Sony Medical Systems. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K931170 · Sony Medical Systems · Radiology device
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Jun 1993
Decision
98d
Days
Class 2
Risk

K931170 is an FDA 510(k) clearance for the SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Sony Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on June 14, 1993 after a review of 98 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.

FDA 510(k) Submission Details - K931170

510(k) Number K931170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date June 14, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
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 198
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K931170.
HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
K933073 · Heartware Intl. Corp. · Oct 1993
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW
K933058 · Heartware Intl. Corp. · Sep 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993
DLX
K926258 · GE Medical Systems · Mar 1993
OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM
K925961 · Diagnostic Archives, Inc. · Mar 1993
CINENET CARDIAC IMAGE NETWORK
K924708 · Sony Medical Systems · Dec 1992
K931170 · SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)
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