TIGERVIEW PROFESSIONAL— 510(k) K061035

Substantially Equivalent

Televere Systems

FDA 510(k) clearance K061035 for TIGERVIEW PROFESSIONAL, Substantially Equivalent on 2006-06-05. Applicant: Televere Systems. Device class: 2.

Clearance details

Applicant
Televere Systems
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mount Airy, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.