The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Intraredx Nir Imaging System, Model Mc-5.
| Device ID | K052908 |
| 510k Number | K052908 |
| Device Name: | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 |
| Contact | Nandini Murthy |
| Correspondent | Nandini Murthy Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2006-06-23 |
| Summary: | summary |