SmartCeph
System, Image Processing, Radiological
Ortho2, LLC
The following data is part of a premarket notification filed by Ortho2, Llc with the FDA for Smartceph.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001048506 | K190162 | 000 |
Trademark Results [SmartCeph]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTCEPH 77409397 not registered Dead/Abandoned |
Ortho Computer Systems, Inc. 2008-02-29 |
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