Cleared Traditional

CINENET CARDIAC IMAGE NETWORK (K924708) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924708 · Sony Medical Systems · Radiology device
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Dec 1992
Decision
103d
Days
Class 2
Risk

K924708 is an FDA 510(k) clearance for the CINENET CARDIAC IMAGE NETWORK. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Sony Medical Systems (Attleboro, US). The FDA issued a Cleared decision on December 30, 1992 after a review of 103 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 Sony Medical Systems devices

Submission Details

510(k) Number K924708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date December 30, 1992
Days to Decision 103 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
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K924708.
COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
K940484 · Siemens Medical Solutions USA, Inc. · Apr 1994
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
ANGIOGRAPHIC X-RAY SYSTEM
K922222 · Siemens Medical Solutions USA, Inc. · Dec 1992
ANGIO-BAND
K923112 · Cook, Inc. · Sep 1992