Radiology · 510(k) · 2022
MRCAT Head & Neck
Philips Oy. Cleared by FDA on 5 April 2022 under submission K214081, product code MUJ (system, planning, radiation therapy treatment). What FDA's record says, in FDA's words.
Device record · K214081
- Device. MRCAT Head & NeckDEVICE
- Company. Philips Oy (FI)COMPANY
- Decision. 5 April 2022, 510(k), substantially equivalent (traditional review); received 27 December 2021DECISION
- 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.
Intended Use: MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning. Indications for use: MRCAT Head and Neck is indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region. Fundamental Scientific Technology: MRCAT Head and Neck functionality is implemented as a software plug-in for the MR main software, and it contains the following main features: 1) Automatic post-processing tool delivering MRCAT images 2) Examcard with mDixon imaging protocol 3) DICOM export of MRCAT image. MRCAT Image Generation MRCAT images are generated with an ExamCard post-processing step, which uses the images from the previous mDixon scan. The post-processing logic takes care of launching MRCAT algorithm executable calculating a new 3D MRCAT image. The post-processing is started once the acquired mDixon MR images have been reconstructed. The first step of MRCAT generation is to pre-process the images to ensure that the MRCAT source images have consistent intensities. The intensity normalized images are then used as input in a convolutional neural network (CNN). The CNN is trained using matched pairs of CT and MRCAT source images. The training of the CNN is locked and is not adapted during use. The output of the CNN is post-processed to create images in CT values. The generated MRCAT images are checked for […]
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.
- Modalities namedCT, MRI
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.
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