The following data is part of a premarket notification filed by Calgary Scientific, Inc. with the FDA for Resolutionmd.
Device ID | K161130 |
510k Number | K161130 |
Device Name: | ResolutionMD |
Classification | System, Image Processing, Radiological |
Applicant | CALGARY SCIENTIFIC, INC. SUITE 208, 1210- 20TH AVENUE SE Calgary, CA T2g 1m8 |
Contact | Kyle Peterson |
Correspondent | Kyle Peterson CALGARY SCIENTIFIC, INC. SUITE 208, 1210- 20TH AVENUE SE Calgary, CA T2g 1m8 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-21 |
Decision Date | 2016-08-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17540262040012 | K161130 | 000 |
17540262040029 | K161130 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RESOLUTIONMD 86188930 4639964 Live/Registered |
Calgary Scientific Inc. 2014-02-10 |
![]() RESOLUTIONMD 85755287 4450008 Live/Registered |
Calgary Scientific Inc. 2012-10-16 |
![]() RESOLUTIONMD 85740724 not registered Dead/Abandoned |
resolutionMD 2012-09-27 |
![]() RESOLUTIONMD 85740720 not registered Dead/Abandoned |
resolutionMD LLC 2012-09-27 |
![]() RESOLUTIONMD 85740709 4664191 Live/Registered |
resolutionMD LLC 2012-09-27 |