The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Ig4 Image Guided System.
| Device ID | K060903 |
| 510k Number | K060903 |
| Device Name: | IG4 IMAGE GUIDED SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VERAN MEDICAL TECHNOLOGIES, INC. 2409 21ST AVENUE SOUTH SUITE 205 Nashville, TN 37212 |
| Contact | Torsten M Lyon |
| Correspondent | Torsten M Lyon VERAN MEDICAL TECHNOLOGIES, INC. 2409 21ST AVENUE SOUTH SUITE 205 Nashville, TN 37212 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815686020705 | K060903 | 000 |
| 00815686020699 | K060903 | 000 |