(29 days)
RiX70 DC X-ray Unit is designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
The subject device is RiX70 DC X-rav Unit and it is an extraoral source dental x-ray system intended for intraoral imaging. The subject device is a device comprised of a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:
- A control unit equipped with wall plate, extension arm and wired control . device.
- A tube head with x-ray tube.
X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique.
The system can be used either with conventional film or a digital imaging system.
The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp.
This submission is for an X-ray unit, which is hardware, not an AI/ML device. Therefore, the questions related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.
Here's an analysis of the provided document focusing on the acceptance criteria and study for the RiX70 DC X-ray Unit:
Acceptance Criteria and Study for RiX70 DC X-ray Unit
The provided document describes the substantial equivalence determination for the RiX70 DC X-ray Unit to a predicate device (RX DC). The acceptance criteria primarily revolve around meeting recognized performance standards and demonstrating similar technological characteristics and safety profiles to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an X-ray unit and not an AI/ML device, the acceptance criteria are based on compliance with electrical, safety, and performance standards. The "reported device performance" reflects the device's conformity to these standards and its characteristics compared to the predicate.
| Acceptance Criteria Category | Specific Criteria (Applied to RiX70 DC) | Reported Device Performance |
|---|---|---|
| Indications for Use / Intended Use | Must be substantially equivalent to predicate device. | Same as Predicate: |
- Designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes.
- Can be used with traditional x-rays (chemicals) or digital x-ray sensors.
- Designed for acquisition of intraoral images of teeth, jaw, and mouth structure for diagnostic purposes. |
| Device Description | Similar core function as the predicate device (extraoral source dental x-ray system for intraoral imaging). | Similar to Predicate: - Double mobile and articulate support arm.
- Control unit with wall plate, extension arm, wired control device.
- Tube head with x-ray tube.
- High frequency and constant potential generators with built-in round collimator.
- High frequency (HF) technology.
- Automatically calculates exposure time based on selected tooth and patient size, or adjustable manually.
- Can be used with conventional film or digital imaging.
- Available in wall-mount and floor-standing configurations.
- 60kVp, 65kVp, and 70kVp selections. |
| Technological Characteristics | Similar operating principles, key components (X-ray tube, HV generator, anode material), and safety features. Any differences must be well-justified and proven equivalent. | Mostly Same/Similar to Predicate: - Principle of use: X-ray tube (Same)
- HV generator: High frequency, Constant potential (Same)
- Anode material: Tungsten (Same)
- Focal spot size: 0.4mm (IEC 60336/1993) (Same)
- Leakage radiation:
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.