ORTHOSCAN MOBILE DI MINI C-ARM— 510(k) K113708
Substantially EquivalentOrthoscan, Inc.
FDA 510(k) clearance K113708 for ORTHOSCAN MOBILE DI MINI C-ARM, Substantially Equivalent on 2012-01-05. Applicant: Orthoscan, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthoscan, Inc.
- Product code
- Code OXO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code OXO
view allMore clearances from Orthoscan, Inc.
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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 →
Recalls naming K113708
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113708.
Data sourced from openFDA. This site is unofficial and independent of the FDA.