510(k) K151426
K151426 is an FDA 510(k) premarket notification submitted by Scandidos AB for the device "ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+". The FDA issued a decision of Substantially Equivalent on January 29, 2016. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Scandidos AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2016
- Date Received
- May 28, 2015
- 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