The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Ig4 Image Guided System, Model: Sys-0200.
| Device ID | K093146 |
| 510k Number | K093146 |
| Device Name: | IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VERAN MEDICAL TECHNOLOGIES, INC. 5743 WEST PARK AVE St. Louis, MO 63110 |
| Contact | Scott Wrightstone |
| Correspondent | Scott Wrightstone VERAN MEDICAL TECHNOLOGIES, INC. 5743 WEST PARK AVE St. Louis, MO 63110 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2009-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815686020927 | K093146 | 000 |
| 00815686020224 | K093146 | 000 |
| 00815686020231 | K093146 | 000 |
| 00815686020248 | K093146 | 000 |
| 00815686020255 | K093146 | 000 |
| 00815686020262 | K093146 | 000 |
| 00815686020279 | K093146 | 000 |
| 00815686020286 | K093146 | 000 |
| 00815686020293 | K093146 | 000 |
| 00815686020309 | K093146 | 000 |
| 00815686020316 | K093146 | 000 |
| 00815686020323 | K093146 | 000 |
| 00815686020330 | K093146 | 000 |
| 00815686020347 | K093146 | 000 |
| 00815686020354 | K093146 | 000 |
| 00815686020361 | K093146 | 000 |
| 00815686020422 | K093146 | 000 |
| 00815686020804 | K093146 | 000 |
| 00815686020217 | K093146 | 000 |