Novo

Digital Pathology Image Viewing And Management Software

PathAI, LLC

The following data is part of a premarket notification filed by Pathai, Llc with the FDA for Novo.

Pre-market Notification Details

• Device ID: K212361
• 510k Number: K212361
• Device Name: Novo
• Classification: Digital Pathology Image Viewing And Management Software
• Applicant: PathAI, LLC 1325 Boylston Avenue Boston, MA 02215
• Contact: Susan Speicher
• Correspondent: Katy Wack; PathAI, LLC 120 Brookline Ave Boston, MA 02215
• Product Code: QKQ
• CFR Regulation Number: 864.3700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-30
• Decision Date: 2022-08-11