510(k) K193173
K193173 is an FDA 510(k) premarket notification submitted by Careray Digital Medical System Co., Ltd. for the device "CareView 1800Le". The FDA issued a decision of Substantially Equivalent on Dec 13, 2019. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Careray Digital Medical System Co., Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2019
- Date Received
- Nov 18, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)