PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM— 510(k) K112974

Substantially Equivalent

Curve Dental, Inc.

FDA 510(k) clearance K112974 for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, Substantially Equivalent on 2011-10-20. Applicant: Curve Dental, Inc..

Clearance details

Applicant
Curve Dental, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orem, UT, 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.