DeviceClearance

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032— 510(k) K071673

Substantially Equivalent

Onc Solutions, Inc.

FDA 510(k) clearance K071673 for ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032, Substantially Equivalent on 2007-07-18. Applicant: Onc Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Onc Solutions, Inc.
Product code
Code IYE
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Manchester, NH, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IYE

view all

Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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.