The following data is part of a premarket notification filed by Exini Diagnostics Ab with the FDA for Exini.
| Device ID | K122205 |
| 510k Number | K122205 |
| Device Name: | EXINI |
| Classification | System, Image Processing, Radiological |
| Applicant | EXINI DIAGNOSTICS AB 9001 WESLEYAN ROAD SUITE 200 Inndianapolis, IN 46268 |
| Contact | Allison Scott |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2012-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002331033 | K122205 | 000 |