Radiology · 510(k) · 2023
RayStation 12A
RaySearch Laboratories AB (publ). Cleared by FDA on 29 March 2023 under submission K222312, product code MUJ (system, planning, radiation therapy treatment). What FDA's record says, in FDA's words.
Device record · K222312
- Device. RayStation 12ADEVICE
- Company. RaySearch Laboratories AB (publ) (SE)COMPANY
- Decision. 29 March 2023, 510(k), substantially equivalent (traditional review); received 1 August 2022DECISION
- Panel. RadiologyPANEL
- Product code. MUJ, System, Planning, Radiation Therapy TreatmentCODE
- Regulation. 21 CFR 892.5050, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 807 reports filed against devices carrying product code MUJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
24 September 2026 · Malfunction · MONACO · Elekta Solutions AB · report 3015232217-2026-00031
The customer reported that the SRS Cone plan export for the counter clockwise beam is not being transferred correctly to MOSAIQ.
22 September 2026 · Malfunction · RayStation · RaySearch Laboratories AB (Publ) · report 3007774465-2026-00003
A user was preparing radiotherapy treatment of the right breast for a patient who had previously received RT to the left breast. The user performed a deformable registration of the two CT scans (prior treatment and current) and mapped the dose onto the current planning CT to create a cumulative dose distribution. The user noticed that the dose in the left breast (from the prior treatment) appeared cut off as it was limited by the size of the dose grid used for the prior treatment. The patient […]
22 September 2026 · Malfunction · RayStation · RaySearch Laboratories AB (Publ) · report 3010034862-2026-00003
A user was preparing radiotherapy treatment of the right breast for a patient who had previously received RT to the left breast. The user performed a deformable registration of the two CT scans (prior treatment and current) and mapped the dose onto the current planning CT to create a cumulative dose distribution. The user noticed that the dose in the left breast (from the prior treatment) appeared cut off as it was limited by the size of the dose grid used for the prior treatment. The patient […]
15 July 2026 · Malfunction · PLANONE 1 · COSYLAB, JSC, CONTROL SYSTEM LABORATORY · report 3014425747-2026-00001
DURING TREATMENT PLAN PREPARATION FOR A PATIENT, IT WAS DISCOVERED THAT COUCH SHIFTS (TREATMENT COUCH TRANSLATIONS REQUIRED TO MOVE THE PATIENT FROM THE REFERENCE/SCANNED POSITION TO THE TREATMENT POSITION) DISPLAYED IN PLANONE DIFFERED FROM THOSE DISPLAYED IN ARIA/ECLIPSE WHEN A PLAN CREATED IN PLANONE WAS TRANSFERRED TO ARIA FOR SCHEDULING. NO PATIENT HARM OCCURRED, AS THE INCONSISTENCY WAS IDENTIFIED DURING THE PLAN PREPARATION PHASE BEFORE TREATMENT DELIVERY. INVESTIGATION IDENTIFIED THE […]
2 June 2026 · Malfunction · MONACO · ELEKTA SOLUTIONS AB · report 3015232217-2026-00016
THE CUSTOMER REPORTED THAT THE NUMBERING OF THE FIRST MRI IN MONACO ALWAYS STARTS WITH MR2, AND ONLY THE SECOND MRI THEN BEARS THE NUMBER MR1.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MUJ, in Radiology, from RaySearch Laboratories AB (publ), or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.