The following data is part of a premarket notification filed by Curvebeam, Llc with the FDA for Cubevue.
| Device ID | K181962 |
| 510k Number | K181962 |
| Device Name: | CubeVue |
| Classification | System, Image Processing, Radiological |
| Applicant | CurveBeam, LLC 175 Titus Ave Suite 300 Warrington, PA 18976 |
| Contact | Stuti Singh |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2018-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863152000379 | K181962 | 000 |
| 00863152000362 | K181962 | 000 |