The following data is part of a premarket notification filed by Dexis Llc with the FDA for Dexis Software.
| Device ID | K090431 |
| 510k Number | K090431 |
| Device Name: | DEXIS SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | DEXIS LLC 1717 WEST COLLINS Orange, CA 92867 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz DEXIS LLC 1717 WEST COLLINS Orange, CA 92867 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101034120 | K090431 | 000 |
| EKAV101034110 | K090431 | 000 |
| EKAV101034090 | K090431 | 000 |
| EKAV101034080 | K090431 | 000 |
| EKAV100879340 | K090431 | 000 |
| D090100879340 | K090431 | 000 |