The following data is part of a premarket notification filed by 3disc Americas with the FDA for Quantorview.
| Device ID | K151687 |
| 510k Number | K151687 |
| Device Name: | QuantorView |
| Classification | System, Image Processing, Radiological |
| Applicant | 3DISC AMERICAS 22560 GLENN DR STE 116 Sterling, VA 20164 |
| Contact | Sigrid Smitt-jeppesen |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-23 |
| Decision Date | 2015-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809466041112 | K151687 | 000 |