Cleared Traditional

K130617 - RAYSTATION

K130617 is an FDA 510(k) clearance for RAYSTATION, manufactured by Raysearch Laboratories AB. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K130617 · Raysearch Laboratories AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
64d
Days
Class 2
Risk

K130617 is an FDA 510(k) clearance for the RAYSTATION. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Raysearch Laboratories AB (Stockholm, SE). The FDA issued a Cleared decision on May 10, 2013 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Raysearch Laboratories AB devices

FDA 510(k) Submission Details - K130617

510(k) Number K130617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date May 10, 2013
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 161
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K130617.
ECLIPSE TREATMENT PLANNING SYSTEM
K133247 · Varian Medical Systems, Inc. · Feb 2014
4D INTEGRATED TREATMENT CONSOLE
K133331 · Varian Medical Systems, Inc. · Jan 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K131891 · Varian Medical Systems, Inc. · Sep 2013
SYNGO RT INTERFACE
K120363 · Siemens Medical Solutions USA, Inc. · Mar 2012
EQUAL DOSE
K103515 · Nucletron Corporation · Sep 2011
MONACO RTP SYSTEM
K110730 · Computerized Medical Systems, Inc. · Jun 2011