510(k) K151180
K151180 is an FDA 510(k) premarket notification submitted by Scandidos AB for the device "ScandiDos Delta4 Phantom+". The FDA issued a decision of Substantially Equivalent on August 19, 2015. 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
- August 19, 2015
- Date Received
- May 4, 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