The following data is part of a premarket notification filed by Invia with the FDA for Corridor4dm.
| Device ID | K080575 | 
| 510k Number | K080575 | 
| Device Name: | CORRIDOR4DM | 
| Classification | System, Tomography, Computed, Emission | 
| Applicant | INVIA 200 Homer Avenue Ashland, MA 01721 | 
| Contact | F. David Rothkopf | 
| Correspondent | F. David Rothkopf INVIA 200 Homer Avenue Ashland, MA 01721 | 
| Product Code | KPS | 
| CFR Regulation Number | 892.1200 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2008-02-29 | 
| Decision Date | 2008-05-13 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CORRIDOR4DM  77506442  3569741 Live/Registered | INVIA LLC 2008-06-24 |