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 |