KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT— 510(k) K970738

Name: FDA 510(k) clearance K970738
Creator: U.S. Food and Drug Administration
Published: 1997-05-07

Substantially Equivalent

Jamieson Film Co.

FDA 510(k) clearance K970738 for KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT, Substantially Equivalent on 1997-05-07. Applicant: Jamieson Film Co.. Device class: 2.

Clearance details

Applicant: Jamieson Film Co.
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 1997-02-28
Decision date: 1997-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZI

view all

K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
K243645 — IC-Flow Imaging System 2.02025-09-22
K243077 — Affirm 8002025-06-27
K231986 — Modus IR2024-03-25

More clearances from Jamieson Film Co.

view all

K971128 — CAP-35B III/CINE 2751997-04-28
K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 21001996-09-11
K960043 — KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM1996-03-27
K953563 — VANGUARD XR-350 CINEANGIOGRAM PROJECTOR1995-10-05
K913241 — JAMIESON JT-CRP CINE FILM PROCESSOR1991-09-24

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.