VIFS

System, X-ray, Tomography, Computed

KONICA MEDICAL CORP.

The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Vifs.

Pre-market Notification Details

• Device ID: K955583
• 510k Number: K955583
• Device Name: VIFS
• Classification: System, X-ray, Tomography, Computed
• Applicant: KONICA MEDICAL CORP. C/O STORCH AMINI & MUNVES, P.C 1090 VERMONT AVE NW, STE 800 Washington, DC 20005
• Contact: Russell D Munves
• Correspondent: Russell D Munves; KONICA MEDICAL CORP. C/O STORCH AMINI & MUNVES, P.C 1090 VERMONT AVE NW, STE 800 Washington, DC 20005
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-05
• Decision Date: 1996-05-14