PIPER

System, Planning, Radiation Therapy Treatment

RTEK MEDICAL SYSTEMS, LLC.

The following data is part of a premarket notification filed by Rtek Medical Systems, Llc. with the FDA for Piper.

Pre-market Notification Details

• Device ID: K001295
• 510k Number: K001295
• Device Name: PIPER
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: RTEK MEDICAL SYSTEMS, LLC. 16 TOBEY VILLAGE OFFICE PARK Pittsford, NY 14534
• Contact: Robert C Jackson
• Correspondent: Robert C Jackson; RTEK MEDICAL SYSTEMS, LLC. 16 TOBEY VILLAGE OFFICE PARK Pittsford, NY 14534
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-24
• Decision Date: 2000-10-25