APROMISE

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 Apromise.

Pre-market Notification Details

• Device ID: K211655
• 510k Number: K211655
• Device Name: APROMISE
• Classification: System, Image Processing, Radiological
• Applicant: EXINI Diagnostics AB Ideon Science Park, Scheelevägen 27 Lund, SE Se-223 70
• Contact: Aseem Anand
• Correspondent: Donna-bea Tillman; Biologics Consulting Group 1555 King Street 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: 2021-05-28
• Decision Date: 2021-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350002335017	K211655	000
07350002336014	K211655	000