Televere Podiatry X-Ray System HF— 510(k) K180765

Name: FDA 510(k) clearance K180765
Creator: U.S. Food and Drug Administration
Published: 2018-04-20

Substantially Equivalent

Televere Systems, Inc.

FDA 510(k) clearance K180765 for Televere Podiatry X-Ray System HF, Substantially Equivalent on 2018-04-20. Applicant: Televere Systems, Inc.. Device class: 2.

Clearance details

Applicant: Televere Systems, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2018-03-23
Decision date: 2018-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MD, US

Download summary PDF View on FDA.gov ↗

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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.