The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Lipiscan Ivus Imaging System Model Nirs-mc7-70.
| Device ID | K093993 |
| 510k Number | K093993 |
| Device Name: | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 |
| Classification | Catheter, Intravascular, Plaque Morphology Evaluation |
| Applicant | Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 -4414 |
| Contact | Steven J Chartier |
| Correspondent | Steven J Chartier Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 -4414 |
| Product Code | OGZ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-06-30 |
| Summary: | summary |