RayStation

System, Planning, Radiation Therapy Treatment

RaySearch Laboratories AB (publ)

The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raystation.

Pre-market Notification Details

• Device ID: K200569
• 510k Number: K200569
• Device Name: RayStation
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm, SE 11134
• Contact: Viktoria Hammarstedt
• Correspondent: Viktoria Hammarstedt; RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm, SE 11134
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-04
• Decision Date: 2020-09-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350002010297	K200569	000