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: K190387
• 510k Number: K190387
• Device Name: RayStation
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: RaySearch Laboratories AB (publ) Sveavagen 44 Stockholm, SE 111 34
• Contact: David Hedfors
• Correspondent: David Hedfors; RaySearch Laboratories AB (publ) Sveavagen 44 Stockholm, SE 111 34
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-19
• Decision Date: 2019-06-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350002010174	K190387	000
07350002010129	K190387	000