VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
VATECH Co., LtdVistaPano S Ceph 2.0 and related models are advanced 2-in-1 digital X-ray imaging systems designed to capture detailed panoramic and cephalometric images of the dento-maxillofacial region, sinus, and TMJ for adult and pediatric patients. It supports orthodontic treatment by also using carpal images. The systems are intended to be operated by medical professionals such as dentists, physicians, and x-ray technicians, improving diagnostic capabilities in dental and maxillofacial care.
Intended Use
The unit is intended to produce panoramic or cephalometric digital X-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment.
Technology
This is an advanced 2-in-1 digital X-ray system incorporating panoramic (PANO) and cephalometric (CEPH) imaging modes with CMOS photodiode array detectors (Xmaru1501CF-PLUS and Xmaru2602CF). It includes an X-ray generator (Canon D-052SB), and operates with imaging software VisionX 3.0. The system uses 14-bit analog-digital conversion, and the CEPH detector offers both 2x2 binning and non-binning modes (HD and SD imaging).
Performance
Performance testing compared the subject device with a predicate device (PaX-i Plus/Insight) confirming similar indications for use, X-ray source, image receptor, and improved or equivalent image quality especially with the new HD mode (non-binning) in CEPH imaging. Safety, EMC, and software validation were completed with satisfactory results according to FDA guidance and international standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/5/2024
9 months - 2
FDA Approval
10/25/2024
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