The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Opensight.
Device ID | K172418 |
510k Number | K172418 |
Device Name: | OpenSight |
Classification | System, Image Processing, Radiological |
Applicant | Novarad Corporation 752 East 1180 South #200 American Fork, UT 84003 |
Contact | Doug Merrill |
Correspondent | Doug Merrill Novarad Corporation 752 East 1180 South #200 American Fork, UT 84003 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-10 |
Decision Date | 2018-09-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B109OPENSIGHT180760 | K172418 | 000 |
B109OPENSIGHT188040 | K172418 | 000 |
B109OPENSIGHT187060 | K172418 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPENSIGHT 87532477 5439844 Live/Registered |
Novarad Corporation 2017-07-18 |
OPENSIGHT 78968718 3665208 Live/Registered |
Dow AgroSciences LLC 2006-09-07 |
OPENSIGHT 77526058 not registered Dead/Abandoned |
Siemens Medical Solutions USA, Inc. 2008-07-18 |