MULTIDOS, QC6PLUS

System, Radiation Therapy, Charged-particle, Medical

PTW-NEW YORK CORP.

The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for Multidos, Qc6plus.

Pre-market Notification Details

• Device ID: K972211
• 510k Number: K972211
• Device Name: MULTIDOS, QC6PLUS
• Classification: System, Radiation Therapy, Charged-particle, Medical
• Applicant: PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710
• Contact: Stephen R Szeglin
• Correspondent: Stephen R Szeglin; PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710
• Product Code: LHN
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-12
• Decision Date: 1997-09-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EPTWT420310	K972211	000
EPTWT420100	K972211	000
EPTWT100060	K972211	000
EPTWT100040	K972211	000