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510(k) Data Aggregation
K Number
K202369Device Name
RXS 1000
Manufacturer
Date Cleared
2021-09-15
(392 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Rolence Enterprise Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.
Device Description
The RXS1000 is intended to acquire real-time, clinical digital intraoral X-ray images using a solidstate imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC(software).
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K Number
K172928Device Name
Portable X-ray System
Manufacturer
Date Cleared
2018-03-16
(172 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Rolence Enterprise Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.
Device Description
XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield.
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