IMSURE

Accelerator, Linear, Medical

PRODIGM, INC.

The following data is part of a premarket notification filed by Prodigm, Inc. with the FDA for Imsure.

Pre-market Notification Details

• Device ID: K031975
• 510k Number: K031975
• Device Name: IMSURE
• Classification: Accelerator, Linear, Medical
• Applicant: PRODIGM, INC. 585 MANZANITA AVE., SUITE #1 Chico, CA 95926
• Contact: Suzanne Wild
• Correspondent: Juergen Welte; TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2003-06-26
• Decision Date: 2003-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00866562000229	K031975	000