I-DIXEL

System, Image Processing, Radiological

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for I-dixel.

Pre-market Notification Details

• Device ID: K073704
• 510k Number: K073704
• Device Name: I-DIXEL
• Classification: System, Image Processing, Radiological
• 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: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-12-31
• Decision Date: 2008-02-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548213030804	K073704	000
04548213026777	K073704	000
04548213026760	K073704	000
04548213025299	K073704	000
04548213025282	K073704	000
04548213025183	K073704	000
04548213025176	K073704	000
04548213024735	K073704	000
04548213024728	K073704	000
04548213024711	K073704	000
04548213024704	K073704	000
04548213026784	K073704	000
04548213026791	K073704	000
04548213026807	K073704	000
04548213026982	K073704	000
04548213026975	K073704	000
04548213026968	K073704	000
04548213026951	K073704	000
04548213026944	K073704	000
04548213026852	K073704	000
04548213026845	K073704	000
04548213026838	K073704	000
04548213026821	K073704	000
04548213026814	K073704	000
04548213024698	K073704	000