MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM— 510(k) K970964

Name: FDA 510(k) clearance K970964
Creator: U.S. Food and Drug Administration
Published: 1997-06-13

Substantially Equivalent

International Imaging Electronics

FDA 510(k) clearance K970964 for MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM, Substantially Equivalent on 1997-06-13. Applicant: International Imaging Electronics. Device class: 2.

Clearance details

Applicant: International Imaging Electronics
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1997-03-17
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bolingbrook, IL, US

Download summary PDF View on FDA.gov ↗

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K953165 — ULTRA COMPACT VIDEO IMAGER1996-05-07
K940332 — MODEL FORTY ULTRA COMPACT VIDEO IMAGER1994-06-08
K934908 — FULL VIEW DIGITAL STORAGE SYSTEM1994-01-28

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.