The following data is part of a premarket notification filed by 3disc Americas with the FDA for Computed Radiography Scanner.
| Device ID | K133120 |
| 510k Number | K133120 |
| Device Name: | COMPUTED RADIOGRAPHY SCANNER |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | 3DISC AMERICAS 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm 3DISC AMERICAS 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817100020476 | K133120 | 000 |
| 00817100020469 | K133120 | 000 |
| 00817100020391 | K133120 | 000 |
| 08809466040412 | K133120 | 000 |
| 08809466040511 | K133120 | 000 |
| 08809466040313 | K133120 | 000 |