CT CoPilot
System, Image Processing, Radiological
ZEPMED, LLC.
The following data is part of a premarket notification filed by Zepmed, Llc. with the FDA for Ct Copilot.
Pre-market Notification Details
| Device ID | K161322 |
| 510k Number | K161322 |
| Device Name: | CT CoPilot |
| Classification | System, Image Processing, Radiological |
| Applicant | ZEPMED, LLC. 2465 Avenida De La Playa La Jolla, CA 92037 |
| Contact | Douglas J. Bates |
| Correspondent | James W. Monroe MONROE MEDICAL DEVICE CONSULTING, LLC 319 Shilling Dr Somerset, NJ 08873 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-12-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000004800 | K161322 | 000 |
Trademark Results [CT CoPilot]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CT COPILOT 86450454 4768307 Live/Registered |
ZepMed, LLC 2014-11-11 |
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