COLOR DISKSTORE— 510(k) K922647

Name: FDA 510(k) clearance K922647
Creator: U.S. Food and Drug Administration
Published: 1992-08-11

Substantially Equivalent

Camtronics, Ltd.

FDA 510(k) clearance K922647 for COLOR DISKSTORE, Substantially Equivalent on 1992-08-11. Applicant: Camtronics, Ltd.. Device class: 2.

Clearance details

Applicant: Camtronics, Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1992-06-03
Decision date: 1992-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hartland, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Camtronics, Ltd.

view all

K021236 — SURGERY AND ACCESSORIES2002-07-17
K013032 — PHYSIOLOG, SERIES 950002002-06-04
K992666 — VIDEO PLUS SYSTEM, SERIES 950001999-10-13
K992259 — ECHOCARDIOGRAPHY SYSTEM SERIES 950001999-09-08
K990066 — CCD CAMERA, MODEL 90001999-03-17

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.