The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Ig 4 Image Guided System.
| Device ID | K093995 |
| 510k Number | K093995 |
| Device Name: | IG 4 IMAGE GUIDED SYSTEM |
| 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 | 2009-12-28 |
| Decision Date | 2010-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815686021061 | K093995 | 000 |