BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6— 510(k) K070611

Name: FDA 510(k) clearance K070611
Creator: U.S. Food and Drug Administration
Published: 2007-07-11

Substantially Equivalent

Nomos Corp.

FDA 510(k) clearance K070611 for BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6, Substantially Equivalent on 2007-07-11. Applicant: Nomos Corp.. Device class: 2.

Clearance details

Applicant: Nomos Corp.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2007-03-05
Decision date: 2007-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranberry Township, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.