KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM— 510(k) K023772

Substantially Equivalent

Acuson Corp.

FDA 510(k) clearance K023772 for KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, Substantially Equivalent on 2002-11-22. Applicant: Acuson Corp..

Clearance details

Applicant
Acuson Corp.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountainview, CA, 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.