(90 days)
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No
The description focuses on the hardware components and conventional control systems of a linear accelerator, with no mention of AI or ML technologies.
Yes
The device is described as being used for "electron or photon radiation treatment of cancer" and provides a "high energy beam of electrons and/or x-rays which is used for the treatment of cancer," which indicates a therapeutic purpose.
No
The device is described as an accelerator for radiation treatment of cancer, not for diagnosing it.
No
The device description clearly outlines multiple hardware components including a control console with keyboard, video display, computers, and control circuits, a gantry stand with power sources, and a rotating gantry with various physical components like an accelerating tube, magnets, and collimator. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "electron or photon radiation treatment of cancer." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a medical linear accelerator used to deliver radiation beams for treatment. It describes components related to generating and controlling radiation, positioning the patient, and monitoring the machine. None of these functions are related to testing samples from the human body to diagnose conditions.
- Lack of IVD Characteristics: An IVD device typically involves analyzing biological samples (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such activities or components.
Therefore, the EXL series of accelerators are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.
Product codes
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Device Description
Medical Linear Accelerators provide a high energy beam of electrons and/or x-rays which is used for the treatment of cancer. The beam produced by the machine is carefully controlled in terms of geometry, energy, uniformity and intensity. The device also provides mechanisms for positioning the patient and controlling the delivery geometry. The accelerators consist of three major subsytems, the Control Console. Gantry Stand, and Rotating Gantry. The control console is the main component for operation and control of the LINAC. It is used to select the machine operation and patient treatment parameters and monitor the machine operating conditions. The new control console for the EXL-DP series of accelerators consists of an operator keyboard, video display, and various computers and control circuits. The Gantry Stand contains the high power sources for the accelerator system, notably the Klystron microwave power, modulator and electromagnet power supplies, The Rotating Gantry contains the accelerating tube, energy switching system, beam bending magnet, x-ray target, collimator, dosimetry system, and various safety features and circuits.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
8970137
APR 1 5 1997
510 (k) SUMMARY
MITSUBISHI LINEAR ACCELERATORS EXL SERIES
1. Submitter:
The 510 (k) is submitted by Mr. Hideyuki Kawakami, Sales Manager, Medical Systems Division, Mitsubishi Electronics America, Inc., Two Tower Bridge, 1 Fayette Street, Suite 100, Conshohocken, PA 19428. This 510 (k) summary was prepared on January 10, 1997.
2. Device Name:
The 510 (k) submission is for EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and computerized control consoles.
3. Predicate device:
The devices described in this submission are considered to be substantially equivalent to the EXL series of Mitsubishi Linear Accelerators utilizing klystron and magnetron power supplies and conventional hard-wired control consoles. The predicate device are legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.
4. Device description
Medical Linear Accelerators provide a high energy beam of electrons and/or x-rays which is used for the treatment of cancer. The beam produced by the machine is carefully controlled in terms of geometry, energy, uniformity and intensity. The device also provides mechanisms for positioning the patient and controlling the delivery geometry.
The accelerators consist of three major subsytems, the Control Console. Gantry Stand, and Rotating Gantry.
The control console is the main component for operation and control of the LINAC. It is used to select the machine operation and patient treatment parameters and monitor the machine operating conditions. The new control console for the EXL-DP series of accelerators consists of an operator keyboard, video display, and various computers and control circuits.
The Gantry Stand contains the high power sources for the accelerator system, notably the Klystron microwave power, modulator and electromagnet power supplies,
The Rotating Gantry contains the accelerating tube, energy switching system, beam bending magnet, x-ray target, collimator, dosimetry system, and various safety features and circuits.
5. Intended use:
1
The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.
6. Comparison of technological characteristics:
This submission describes the modification of existing Mitsubishi EXL series of accelerators by the replacement of the conventional hard-wired operator console with the computerized console. There has been no change to the traditional treatment beam control circuit, dosimetry monitor circuit and interlock circuit from the currently marketed LINACS. Likewise, there has been no change in the function or performance specifications or characteristics. The technology used to set the operating parameters is transparent to the gantry and gantry stand where actual beam generation and delivery takes place.