SAMSUNG RAYPAX FILM DIGITIZER— 510(k) K992112

Name: FDA 510(k) clearance K992112
Creator: U.S. Food and Drug Administration
Published: 1999-09-09

Substantially Equivalent

Samsung Sds Co., Ltd.

FDA 510(k) clearance K992112 for SAMSUNG RAYPAX FILM DIGITIZER, Substantially Equivalent on 1999-09-09. Applicant: Samsung Sds Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Sds Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1999-06-22
Decision date: 1999-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aubrey, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K002062 — SAMSUNG 10DR IMPLANT SYSTEM2000-11-09
K992426 — RAYPAX WEB CLINICAL SYSTEM1999-10-13
K992306 — SAMSUNG RAYPAX DISPLAY WORKSTATION1999-09-22
K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE1999-09-13
K991537 — SAMSUNG RAYPAX SYSTEM1999-07-06

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.