Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution And Accessories

Accelerator, Linear, Medical

Qfix

The following data is part of a premarket notification filed by Qfix with the FDA for Qfix® Abdominal/thoracic Motion Control System,qfix® Sbrt Solution And Accessories.

Pre-market Notification Details

• Device ID: K171133
• 510k Number: K171133
• Device Name: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution And Accessories
• Classification: Accelerator, Linear, Medical
• Applicant: Qfix 440 Church Road Avondale, PA 19311
• Contact: Alexandra Nicole Low
• Correspondent: Alexandra Nicole Low; Qfix 440 Church Road Avondale, PA 19311
• Product Code: IYE
• Subsequent Product Code: JAI
• Subsequent Product Code: JAK
• Subsequent Product Code: KPS
• Subsequent Product Code: LHN
• Subsequent Product Code: LNH
• Subsequent Product Code: OUO
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-17
• Decision Date: 2017-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841962111123	K171133	000
00841962119771	K171133	000
00841962119689	K171133	000
00841439114841	K171133	000