The following data is part of a premarket notification filed by Clario Medical Imaging, Inc. with the FDA for Z3d Contrast Acuity.
| Device ID | K080196 |
| 510k Number | K080196 |
| Device Name: | Z3D CONTRAST ACUITY |
| Classification | System, Image Processing, Radiological |
| Applicant | CLARIO MEDICAL IMAGING, INC. 1924 FIRST AVE., SUITE 4W Seattle, WA 98101 |
| Contact | Chris Wood |
| Correspondent | Chris Wood CLARIO MEDICAL IMAGING, INC. 1924 FIRST AVE., SUITE 4W Seattle, WA 98101 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864747000231 | K080196 | 000 |