VascuCAP
System, Image Processing, Radiological
Elucid Bioimaging Inc.
The following data is part of a premarket notification filed by Elucid Bioimaging Inc. with the FDA for Vascucap.
Pre-market Notification Details
| Device ID | K183012 |
| 510k Number | K183012 |
| Device Name: | VascuCAP |
| Classification | System, Image Processing, Radiological |
| Applicant | Elucid Bioimaging Inc. 225 Main Street Wenham, MA 01984 |
| Contact | Andrew Buckler |
| Correspondent | Andrew Buckler Elucid Bioimaging Inc. 225 Main Street Suite 15 Wenham, MA 01984 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B745A40 | K183012 | 000 |
| B745VASCUCAPA2 | K183012 | 000 |
Trademark Results [VascuCAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VASCUCAP 86490940 4887988 Live/Registered |
Elucid Bioimaging Inc. 2014-12-27 |
 VASCUCAP 86182064 4636011 Live/Registered |
Elucid Bioimaging Inc. 2014-02-02 |
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