SIENET DIAGNOSTIC REPORTING CONSOLE— 510(k) K920309

Name: FDA 510(k) clearance K920309
Creator: U.S. Food and Drug Administration
Published: 1992-03-20

Substantially Equivalent

Siemens Gammasonics, Inc.

FDA 510(k) clearance K920309 for SIENET DIAGNOSTIC REPORTING CONSOLE, Substantially Equivalent on 1992-03-20. Applicant: Siemens Gammasonics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Gammasonics, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1992-01-23
Decision date: 1992-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

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K933664 — POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)1993-12-15
K933256 — FAN BEAM COLLIMATOR1993-10-29
K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI1992-10-20
K923582 — SIENET CAMERA SERVER1992-10-14

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.