The following data is part of a premarket notification filed by Nanoray Biotech Co., Ltd with the FDA for Hand Diagnostic Radiography Imaging System.
| Device ID | K220271 |
| 510k Number | K220271 |
| Device Name: | Hand Diagnostic Radiography Imaging System |
| Classification | System, X-ray, Stationary |
| Applicant | NanoRay Biotech Co., Ltd 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City, TW 114 |
| Contact | Alice Chen |
| Correspondent | Alice Chen NanoRay Biotech Co., Ltd 7F., No.91, Xinhu 1st Rd., Neihu Dist. Taipei City, TW 114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719892352000 | K220271 | 000 |