3D Echo— 510(k) K172513

Substantially Equivalent

Jointvue, LLC

FDA 510(k) clearance K172513 for 3D Echo, Substantially Equivalent on 2017-09-14. Applicant: Jointvue, LLC.

Clearance details

Applicant
Jointvue, LLC
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Knoxville, TN, US
Download summary PDFView on FDA.gov ↗

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.