IntelePACS

System, Image Processing, Radiological

INTELERAD MEDICAL SYSTEMS INCORPORATED

The following data is part of a premarket notification filed by Intelerad Medical Systems Incorporated with the FDA for Intelepacs.

Pre-market Notification Details

• Device ID: K150707
• 510k Number: K150707
• Device Name: IntelePACS
• Classification: System, Image Processing, Radiological
• Applicant: INTELERAD MEDICAL SYSTEMS INCORPORATED 895 DE LA GAUCHETIERE ST WEST, SUITE 400 Montreal, CA H3b 4g1
• Contact: Ms. Luce Caron
• Correspondent: Carl Alletto; OTech Inc. 8317 Belew Drive Mckinney, TX 75071
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-19
• Decision Date: 2015-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B228INTELEPACS0	K150707	000