EMBRACE

System, X-ray, Mammographic

IZI MEDICAL PRODUCTS INC.

The following data is part of a premarket notification filed by Izi Medical Products Inc. with the FDA for Embrace.

Pre-market Notification Details

• Device ID: K101373
• 510k Number: K101373
• Device Name: EMBRACE
• Classification: System, X-ray, Mammographic
• Applicant: IZI MEDICAL PRODUCTS INC. 7020 TUDSBURY RD. Baltimore, MD 21244
• Contact: Helen Shafer
• Correspondent: Helen Shafer; IZI MEDICAL PRODUCTS INC. 7020 TUDSBURY RD. Baltimore, MD 21244
• Product Code: IZH
• CFR Regulation Number: 892.1710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-17
• Decision Date: 2010-09-15
• Summary: summary