The following data is part of a premarket notification filed by Clear Guide Medical with the FDA for Clear Guide Scenergy.
| Device ID | K153004 |
| 510k Number | K153004 |
| Device Name: | Clear Guide SCENERGY |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | CLEAR GUIDE MEDICAL 3600 Clipper Mill Road, Suite 400 Baltimore, MD 21211 |
| Contact | Jack Kent |
| Correspondent | Jack Kent CLEAR GUIDE MEDICAL 3600 Clipper Mill Road, Suite 400 Baltimore, MD 21211 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B201CGSCENERGY1 | K153004 | 000 |
| B201CGCORE240 | K153004 | 000 |