510(k) K220700
K220700 is an FDA 510(k) premarket notification submitted by Yian Medical Technology (Haining) Co., Ltd. for the device "Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine". The FDA issued a decision of Substantially Equivalent on May 4, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Yian Medical Technology (Haining) Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2022
- Date Received
- March 10, 2022
- 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