Achilles EXPII

Achilles EXPII - v1

An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MUA

Device Name: Bone Sonometer

Device Class: 2

Physical State: N/A

Definition: A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal. Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1180

Third Party Flag: N

Medical Specialty: RA

Device Id: 00840682116978

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

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Package Type: N/A