Search Results
Found 2 results
510(k) Data Aggregation
K Number
K212144Device Name
Remex KA6
Manufacturer
Remedi Co. Ltd.
Date Cleared
2021-08-03
(25 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Remedi Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
Device Description
The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
Ask a Question
K Number
K200284Device Name
R-Sensor, R-Sensor
Manufacturer
Remedi Co. Ltd.
Date Cleared
2020-02-28
(23 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Remedi Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The R-Sensor dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
Device Description
The subject R-Sensor is an intraoral digital x-ray system comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Management Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
R-Sensor, Size 1 is also known as factory code S11684-12; R-Sensor, Size 2 is also known as factory code S116845-12.
Ask a Question
Page 1 of 1