510(k) K113708
K113708 is an FDA 510(k) premarket notification submitted by Orthoscan, Inc. for the device "ORTHOSCAN MOBILE DI MINI C-ARM". The FDA issued a decision of Substantially Equivalent on January 5, 2012. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Orthoscan, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2012
- Date Received
- December 16, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Fluoroscopy of the human body.