The following data is part of a premarket notification filed by Shanghai Pz Medical Technolgoy Co., Ltd. with the FDA for Models 3543a, 4343a, 2929a And A843b.
| Device ID | K170480 |
| 510k Number | K170480 |
| Device Name: | Models 3543A, 4343A, 2929A And A843B |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Shanghai PZ Medical Technolgoy Co., Ltd. 5F, Building 13 No.2 Suide Road Shanghai, CN 200331 |
| Contact | Jeff Moeller |
| Correspondent | Jeff Moeller OrganizeUS, Inc. 8317 Lakeside Drive Downers Grove, IL 60516 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-07-07 |
| Summary: | summary |