IRAD

System, Image Processing, Radiological

Claritas HealthTech Pte Ltd

The following data is part of a premarket notification filed by Claritas Healthtech Pte Ltd with the FDA for Irad.

Pre-market Notification Details

• Device ID: K212470
• 510k Number: K212470
• Device Name: IRAD
• Classification: System, Image Processing, Radiological
• Applicant: Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443
• Contact: Devika Dutt
• Correspondent: Devika Dutt; Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-06
• Decision Date: 2021-10-20