510(k) K170755
K170755 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "DRX-Revolution Nano Mobile X-ray System". The FDA issued a decision of Substantially Equivalent on Jun 21, 2017. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Carestream Health, Inc. has 52 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 2017
- Date Received
- Mar 13, 2017
- Clearance Type
- Traditional
- 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)