DeviceClearance

DR VISION NEO, DR VISION DOU— 510(k) K080614

Substantially Equivalent

Almana Medical Imaging

FDA 510(k) clearance K080614 for DR VISION NEO, DR VISION DOU, Substantially Equivalent on 2008-06-20. Applicant: Almana Medical Imaging.

Clearance details

Applicant
Almana Medical Imaging
Product code
Code KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

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.