(83 days)
Kaycor International's Panoura ULTRA Pan/Ceph X-Ray Unit, Kaycor International's Panoura-10C Pan/Ceph X-Ray Unit, J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System
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No
The summary describes a standard dental x-ray system with mechanical components for patient positioning. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
This device is an X-ray system used for diagnostic imaging (taking dental X-rays), not for treating conditions.
No
The device is an imaging device used to acquire x-ray images, but it does not claim to perform any analysis or diagnosis based on those images. Its intended use is solely for taking panoramic and cephalometric dental x-rays.
No
The device description explicitly lists multiple hardware components (x-ray control unit, x-ray upright assembly, x-ray head, collimator, cephalometer, patient positioning assembly with various parts). This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This device is used to take X-rays of a patient's head.
- The intended use is for taking dental X-rays. This is an imaging procedure performed directly on the patient, not on a biological sample.
- The device description details components for positioning the patient and generating X-rays. These are characteristic of imaging devices, not IVDs.
This device is a medical imaging device, specifically a dental X-ray system.
N/A
Intended Use / Indications for Use
J.Morita USA, Inc.'s Versaview Panoramic-Cephalometric Dental X-Ray System ("Panoramic/Cephalometric System") is intended to take panoramic and cephalometric dental x-rays including anteriorposterior, posterior-anterior, and submentovortex views.
To take panoramic and cephalometric dental x-rays including anterior-posterior, posterior-anterior and submentovortex views.
Product codes (comma separated list FDA assigned to the subject device)
90 EHD
Device Description
The modified device consists of a x-ray control unit, x-ray upright assembly, x-ray head, collimator, and cephalometer. The upright assembly and cephalometer have a patient positioning assembly which is used to position and hold the patient's head during a dental x-ray. The patient positioning assembly on the upright assembly consists of a forehead stabilizer, zygoma stabilizer, bite block, bite block cover, and chin rest. The patient positioning assembly on the cephalometer consists of forehead stabilizer, rearhead stabilizer, and ear rod.
To take a x-ray, the dentist positions the patient in one of the patient positioning assemblies and loads the film cassette on the cassette holder. If taking panoramic x-rays, the dentist adjusts the exposure voltage and amperage. If taking a cephalometric xray, the dentist adjusts the exposure voltage and time. The exposure amperage in cephalometric x-ray mode is automatically set at 10 milliamps. The dentist presses the emission button on the control unit's handswitch to take the x-ray. After the exposure is complete, the patient can move away from the x-ray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-Ray
Anatomical Site
Dental
Indicated Patient Age Range
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Intended User / Care Setting
Dentist
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.
Kaycor International's Panoura ULTRA Pan/Ceph X-Ray Unit, Kaycor International's Panoura-10C Pan/Ceph X-Ray Unit, J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
| OR | Over-The-Counter Use |
|-------------------------|----------------------------------------------------------|----|----------------------|
| (Per 21 C.F.R. 801.109) | | | |
(Optional Format 1-2-96)
79228.W11