Cleared Traditional

K970738 - KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT

K970738 is an FDA 510(k) clearance for KODAK DIGITAL SCIENCE CARDIAC DIGITAL A..., manufactured by Jamieson Film Co.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K970738 · Jamieson Film Co. · Radiology device
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May 1997
Decision
68d
Days
Class 2
Risk

K970738 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Jamieson Film Co. (Rochester, US). The FDA issued a Cleared decision on May 7, 1997 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jamieson Film Co. devices

FDA 510(k) Submission Details - K970738

510(k) Number K970738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1997
Decision Date May 07, 1997
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
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 140
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