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510(k) Data Aggregation
K Number
K160857Device Name
HF 718BD X-Ray System
Manufacturer
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION
Date Cleared
2017-02-24
(332 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.
Device Description
The new MODEL HF 718BD X-RAY SYSTEM is a stationary x-ray system for imaging of peripheral extremities. The new MODEL HF 718BD X-RAY SYSTEM is based on the predicate Model 715BD Series X-Ray System. The modifications to the Model 715BD Series X-Ray System to create the new MODEL HF 718BD X-RAY SYSTEM are summarized as:
1. The analog high voltage power supply in the predicate Model 715BD Series is replaced by a high-frequency high-voltage power supply in the new MODEL HF 718BD X-RAY SYSTEM.
2. The line frequency counting technology of the exposure timer in the predicate Model 715BD Series is replaced by a crystal controlled digital exposure timing system in the new MODEL HF 718BD X-RAY SYSTEM.
3. The current technique factors are moderately decreased from fixed 15 mA to fixed 10 mA in the new MODEL HF 718BD X-RAY SYSTEM.
4. The voltage display on the predicate Model 715BD is an analog meter. With the new MODEL HF 718BD X-RAY SYSTEM, the user sets the kV and exposure time (can be stored as a user preset) and the pre-set values are presented to the user on a digital display.
The Source to Detector distance for the new MODEL HF 718BD X-RAY SYSTEM is 29 inches, which is identical to the predicate Model 715BD. In addition to the exposure control microcontroller in the predicate Model 715BD Series, an additional microcontroller is applied in the power supply to receive communication of kV by the xray control unit in the new MODEL HF 718BD X-RAY SYSTEM.
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