SHADOWFORM

System, Simulation, Radiation Therapy

I.Z.I. MEDICAL PRODUCTS CORP.

The following data is part of a premarket notification filed by I.z.i. Medical Products Corp. with the FDA for Shadowform.

Pre-market Notification Details

• Device ID: K964972
• 510k Number: K964972
• Device Name: SHADOWFORM
• Classification: System, Simulation, Radiation Therapy
• Applicant: I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT Owings Mills, MD 21117
• Contact: E.j. Smith
• Correspondent: E.j. Smith; I.Z.I. MEDICAL PRODUCTS CORP. 10 STREAM COURT Owings Mills, MD 21117
• Product Code: KPQ
• CFR Regulation Number: 892.5840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-12
• Decision Date: 1997-05-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815212022074	K964972	000
00815212022067	K964972	000
00815212022050	K964972	000
00815212021749	K964972	000
00815212021732	K964972	000
00815212021725	K964972	000
00815212021718	K964972	000
00815212021701	K964972	000
00815212021695	K964972	000