Saige-Dx

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

DeepHealth, Inc.

The following data is part of a premarket notification filed by Deephealth, Inc. with the FDA for Saige-dx.

Pre-market Notification Details

• Device ID: K220105
• 510k Number: K220105
• Device Name: Saige-Dx
• Classification: Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
• Applicant: DeepHealth, Inc. 1000 Massachusetts Avenue Cambridge, MA 01238
• Contact: B. Nathan Hunt
• Correspondent: B. Nathan Hunt; DeepHealth, Inc. 1000 Massachusetts Avenue Cambridge, MA 01238
• Product Code: QDQ
• CFR Regulation Number: 892.2090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-12
• Decision Date: 2022-05-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860005144013	K220105	000