The following data is part of a premarket notification filed by Ortho2, Llc with the FDA for Smartceph.
Device ID | K190162 |
510k Number | K190162 |
Device Name: | SmartCeph |
Classification | System, Image Processing, Radiological |
Applicant | Ortho2, LLC 1107 Buckeye Avenue Ames, IA 50010 |
Contact | Amy Schmidt |
Correspondent | Ed Johansen W. Edward Johansen 1239 Stanford Street, #205 Santa Monica, CA 90404 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-31 |
Decision Date | 2019-10-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860001048506 | K190162 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMARTCEPH 77409397 not registered Dead/Abandoned |
Ortho Computer Systems, Inc. 2008-02-29 |