MAMMOMAT INSPIRATION PRIME

Full Field Digital, System, X-ray, Mammographic

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammomat Inspiration Prime.

Pre-market Notification Details

• Device ID: K123520
• 510k Number: K123520
• Device Name: MAMMOMAT INSPIRATION PRIME
• Classification: Full Field Digital, System, X-ray, Mammographic
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Contact: Patricia D Jones
• Correspondent: Patricia D Jones; SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406
• Product Code: MUE
• CFR Regulation Number: 892.1715 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-15
• Decision Date: 2013-06-11
• Summary: summary