The following data is part of a premarket notification filed by Invia with the FDA for Corridor4dm V2010 Model: V2010.
| Device ID | K101279 |
| 510k Number | K101279 |
| Device Name: | CORRIDOR4DM V2010 MODEL: V2010 |
| Classification | System, Image Processing, Radiological |
| Applicant | INVIA 200 Homer Avenue Ashland, MA 01721 |
| Contact | David Rothkopf |
| Correspondent | David Rothkopf INVIA 200 Homer Avenue Ashland, MA 01721 |
| Product Code | LLZ |
| Subsequent Product Code | JAK |
| Subsequent Product Code | KPS |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864974000257 | K101279 | 000 |
| 00864974000233 | K101279 | 000 |
| 00864974000226 | K101279 | 000 |
| 00864974000219 | K101279 | 000 |
| 00864974000202 | K101279 | 000 |