ABSI
System, Image Processing, Radiological
EXINI Diagnostics AB
The following data is part of a premarket notification filed by Exini Diagnostics Ab with the FDA for Absi.
Pre-market Notification Details
| Device ID | K191262 |
| 510k Number | K191262 |
| Device Name: | ABSI |
| Classification | System, Image Processing, Radiological |
| Applicant | EXINI Diagnostics AB Ideon Science Park, Scheelevagen 27 Lund, SE Se-223 70 |
| Contact | Aseem Anand |
| Correspondent | Donna-bea Tillman Biologics Consulting 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-08-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002332030 | K191262 | 000 |
| 07350002333037 | K191262 | 000 |
Trademark Results [ABSI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABSI 74733364 not registered Dead/Abandoned |
AB SOFTWARE, INC. 1995-09-22 |
 ABSI 74733361 2085319 Dead/Cancelled |
AB SOFTWARE, INC. 1995-09-22 |
 ABSI 74733360 not registered Dead/Abandoned |
AB SOFTWARE, INC. 1995-09-22 |
 ABSI 74732744 2045536 Dead/Cancelled |
AB SOFTWARE, INC. 1995-09-22 |
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