(87 days)
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No
The summary describes a traditional radiation therapy simulator with mechanical controls and imaging components, with no mention of AI or ML capabilities.
No.
The device is used for simulating and confirming the radiation field, not for directly delivering therapeutic radiation.
No
The device is described as a "Radiation Therapy Simulator" used for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field. It simulates treatment and confirms field size, but it does not diagnose a medical condition.
No
The device description clearly outlines physical hardware components such as a stand, gantry, x-ray tube housing assembly, collimator, image intensifier, cassette holder, control console, hand pendants, and patient couch. This indicates it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied." This describes a process performed on the patient using imaging, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical machine with an x-ray system, gantry, collimator, image intensifier, and patient couch. This is consistent with an imaging and simulation device used in a clinical setting, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health. This device is used for imaging and planning radiation therapy, which is a treatment process performed directly on the patient.
N/A
Intended Use / Indications for Use
The Ximatron Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.
Product codes
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Device Description
The Varian Ximatron C-Series Radiation Therapy Simulator consists of a stand that supports a gantry and houses various electronic support functions. The gantry houses an x-ray tube housing assembly and supports a collimator and image intensifier with a rotatable cassette holder. Mechanical motions of the Ximatron can be controlled from the control console or hand pendants in the simulator room. The patient couch can also be controlled from side panel controls mounted on the couch.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
fluoroscopic and/or radiographic x-ray system
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.
0
K9641/38
Summary of Summary of Information
JAN | 0 1997
| 1. Submitter: | Varian Oncology Systems
3045 Hanover Street
Palo Alto, CA 94304 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Charles H. Will, Manager
Regulatory Compliance & Safety
Phone (415) 424-5036
FAX (415) 424-4830
cwill@os.varian.com |
| | Prepared: October 11, 1996 |
| 2. Device Name: | Varian Ximatron C-Series Radiation Therapy Simulator
with Version 4.2 Software |
| 3. Predicate
Device: | Varian Ximatron C-Series Radiation Therapy Simulator,
cleared October 28, 1985, 510(k) No. K853349 |
| 4. Description: | The Varian Ximatron C-Series Radiation Therapy Simulator
consists of a stand that supports a gantry and houses various
electronic support functions. The gantry houses an x-ray tube
housing assembly and supports a collimator and image
intensifier with a rotatable cassette holder. Mechanical motions
of the Ximatron can be controlled from the control console or
hand pendants in the simulator room. The patient couch can
also be controlled from side panel controls mounted on the
couch. |
| 5. Intended Use: | The Ximatron Radiation Therapy Simulator is to be used in
radiation therapy simulation, using a fluoroscopic and/or
radiographic x-ray system for visualizing the volume to be
exposed during radiation therapy and confirming the position and
size of the therapeutic irradiation field to be applied. |
| 6.Technological
Considerations: | The Ximatron simulator reported in this 510(k) is substantially
equivalent to the device reported in the prior 510(k). It includes
a software controlled feature, Dynamic Motion Management
(DMM), which prevents any mechanical part of the Ximatron
from colliding with any other part, taking into account a volume,
selectable by size, to include the patient. Also included are
Delta GoTo, Auto Tracking with Fluoro, and Mouse features. |
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