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