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510(k) Data Aggregation
K Number
K222896Device Name
AirRay
Manufacturer
Date Cleared
2022-12-20
(88 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
POSKOM Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists.
Indication:
The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts.
The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device must be used for stand mounted imaging of the chest.
Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Contraindication:
The use of X-radiation for diagnostic purposes in the following subjects is contraindicated.
- Pregnancy, especially first trimester
Device Description
The device is intended to assist the diagnosis of bones and tissues through X-ray exposure using an imaging receptor. The image receptor (an integral part of a complete diagnostic system) is not part of this submission.
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