510(k) K203782
K203782 is an FDA 510(k) premarket notification submitted by Nano-X Imaging , Ltd. for the device "Nanox Cart X-ray System". The FDA issued a decision of Substantially Equivalent on April 1, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Nano-X Imaging , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2021
- Date Received
- December 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type