TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915— 510(k) K022565

Name: FDA 510(k) clearance K022565
Creator: U.S. Food and Drug Administration
Published: 2002-10-08

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K022565 for TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915, Substantially Equivalent on 2002-10-08. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2002-08-02
Decision date: 2002-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.