The following data is part of a premarket notification filed by Yian Medical Technology (haining) Co., Ltd with the FDA for Heart5r-110 Portable X-ray Machine, Heart3r-110 Portable X-ray Machine.
| Device ID | K220700 |
| 510k Number | K220700 |
| Device Name: | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine |
| Classification | System, X-ray, Mobile |
| Applicant | Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing, CN |
| Contact | Zhiqin Yu |
| Correspondent | Zhiqin Yu Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing, CN |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-10 |
| Decision Date | 2022-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975023416029 | K220700 | 000 |
| 06975023416012 | K220700 | 000 |