3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17

System, X-ray, Tomography, Computed

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for 3d Accu-i-tomo Xyz Slice View Tomograph, Model Mct-1f8/f17.

Pre-market Notification Details

• Device ID: K073695
• 510k Number: K073695
• Device Name: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
• Classification: System, X-ray, Tomography, Computed
• Applicant: J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 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: 2007-12-31
• Decision Date: 2008-04-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548213025046	K073695	000
04548213018611	K073695	000
04548213016341	K073695	000