PVmed Contouring Software— 510(k) K210916

Substantially Equivalent

Perception Vision Medical Technologies Ltd.Co.

FDA 510(k) clearance K210916 for PVmed Contouring Software, Substantially Equivalent on 2021-12-03. Applicant: Perception Vision Medical Technologies Ltd.Co..

Clearance details

Applicant
Perception Vision Medical Technologies Ltd.Co.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangzhou, CN
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.