VORTECH'S FILM DIGITIZER, FD-1— 510(k) K915362

Name: FDA 510(k) clearance K915362
Creator: U.S. Food and Drug Administration
Published: 1992-04-06

Substantially Equivalent

Vortech Data, Inc.

FDA 510(k) clearance K915362 for VORTECH'S FILM DIGITIZER, FD-1, Substantially Equivalent on 1992-04-06. Applicant: Vortech Data, Inc.. Device class: 2.

Clearance details

Applicant: Vortech Data, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1991-11-27
Decision date: 1992-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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K924366 — PERSONAL DISPLAY SYSTEM1993-04-07
K925097 — VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)1993-01-15
K924229 — VG-A MIG1992-11-27
K922310 — VORTECH'S PERSONAL DISPLAY SYSTEM1992-07-30
K914834 — VORTECH 3M NETWORK PRINTING1992-03-06

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.