The following data is part of a premarket notification filed by Curvebeam, Llc with the FDA for In Reach.
| Device ID | K170789 |
| 510k Number | K170789 |
| Device Name: | In Reach |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-03-16 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863152000331 | K170789 | 000 |
| 00863152000324 | K170789 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IN REACH 86216091 4757074 Live/Registered |
CurveBeam, LLC 2014-03-10 |
![]() IN REACH 77046448 not registered Dead/Abandoned |
Blue Cross and Blue Shield Association 2006-11-17 |
![]() IN REACH 75150756 not registered Dead/Abandoned |
Secure Technologies, Inc. 1996-07-29 |