ADAS 3D

System, Image Processing, Radiological

Adas3D Medical S.L

The following data is part of a premarket notification filed by Adas3d Medical S.l with the FDA for Adas 3d.

Pre-market Notification Details

• Device ID: K212421
• 510k Number: K212421
• Device Name: ADAS 3D
• Classification: System, Image Processing, Radiological
• Applicant: Adas3D Medical S.L Paris 179, 2-2 Barcelona, ES 08036
• Contact: Antonio Riu
• Correspondent: Antonio Riu; Adas3D Medical S.L Paris 179, 2-2 Barcelona, ES 08036
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-04
• Decision Date: 2021-09-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08437021722024	K212421	000