VOXEL FLINGER(TM) 3-D IMAGING SYSTEM— 510(k) K883476

Name: FDA 510(k) clearance K883476
Creator: U.S. Food and Drug Administration
Published: 1988-11-23

Substantially Equivalent

Reality Imaging Corp.

FDA 510(k) clearance K883476 for VOXEL FLINGER(TM) 3-D IMAGING SYSTEM, Substantially Equivalent on 1988-11-23. Applicant: Reality Imaging Corp.. Device class: 2.

Clearance details

Applicant: Reality Imaging Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1988-08-16
Decision date: 1988-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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K912410 — COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM1991-08-13

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.