AGFA DIAGNOSTIC CENTER (ADC)— 510(k) K904519

Name: FDA 510(k) clearance K904519
Creator: U.S. Food and Drug Administration
Published: 1991-06-21

Substantially Equivalent

Enhanced Imaging Technologies, Inc.

FDA 510(k) clearance K904519 for AGFA DIAGNOSTIC CENTER (ADC), Substantially Equivalent on 1991-06-21. Applicant: Enhanced Imaging Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Enhanced Imaging Technologies, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1990-10-03
Decision date: 1991-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield Park, NJ, US

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Recent devices under product code LLZ

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More clearances from Enhanced Imaging Technologies, Inc.

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K912896 — DIGISTORE 21001991-08-26
K903238 — AFGA VIDEO IMAGER, VARIOUS MODELS1990-11-02
K891924 — SCOPIX LASER IMAGER1989-05-18

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.