The following data is part of a premarket notification filed by Behold.ai Technologies Limited with the FDA for Red Dot.
| Device ID | K191556 |
| 510k Number | K191556 |
| Device Name: | Red Dot |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Behold.AI Technologies Limited 91-97 Bohemia Road St. Leonards-on-sea, GB Tn37 6rj |
| Contact | Simon Rasalingham |
| Correspondent | John J. Smith Hogan Lovells US LPP 555 13th Street, NW Washington, DC 20004 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2020-02-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RED DOT 98466422 not registered Live/Pending |
Swearingen 3D Works, LLC 2024-03-25 |
![]() RED DOT 98434092 not registered Live/Pending |
Nicaragua American Cigar, S.A. 2024-03-05 |
![]() RED DOT 90447514 not registered Live/Pending |
Nicaragua American Cigar, S.A. 2021-01-04 |
![]() RED DOT 90318505 not registered Live/Pending |
Miller, Reuben A 2020-11-13 |
![]() RED DOT 90242338 not registered Live/Pending |
Dentless, LLC 2020-10-08 |
![]() RED DOT 88380053 not registered Live/Pending |
Behold.ai Technologies Limited 2019-04-10 |
![]() RED DOT 87400527 not registered Dead/Abandoned |
XU ZHISHAN 2017-04-06 |
![]() RED DOT 86933843 5272121 Live/Registered |
Hankscraft Inc. 2016-03-09 |
![]() RED DOT 86926234 5320063 Live/Registered |
3M Company 2016-03-02 |
![]() RED DOT 85194881 4086467 Live/Registered |
ABB ASEA BROWN BOVERI LTD 2010-12-10 |
![]() RED DOT 85192008 4008945 Dead/Cancelled |
Red Dot Corporation 2010-12-07 |
![]() RED DOT 85148316 4046757 Dead/Cancelled |
Nicaragua American Cigar, S.A. 2010-10-08 |