510(k) K161345
K161345 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR". The FDA issued a decision of Substantially Equivalent on Jul 6, 2016. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Sedecal., Sa. has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 6, 2016
- Date Received
- May 13, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)