510(k) K103193
K103193 is an FDA 510(k) premarket notification submitted by Standard Imaging, Inc. for the device "DOSEVIEW 3D". The FDA issued a decision of Substantially Equivalent on December 27, 2010. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Standard Imaging, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2010
- Date Received
- October 29, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type