510(k) K103633
K103633 is an FDA 510(k) premarket notification submitted by Ge Medical Systems China Co., Ltd. for the device "ACHILLES". The FDA issued a decision of Substantially Equivalent on May 11, 2011. The device falls under product code MUA (Bone Sonometer), a Class II device regulated under 21 CFR 892.1180. Ge Medical Systems China Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2011
- Date Received
- December 13, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Sonometer
- Device Class
- Class II
- Regulation Number
- 892.1180
- Review Panel
- RA
- Submission Type
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