K211350 is an FDA 510(k) clearance for the Bindex BI-2. This device is classified as a Bone Sonometer (Class II - Special Controls, product code MUA).
Submitted by Bone Index Finland , Ltd. (Kuopio, FI). The FDA issued a Cleared decision on April 29, 2022, 361 days after receiving the submission on May 3, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1180. 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.
| 510(k) Number | K211350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 361 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUA - Bone Sonometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1180 |
| 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 |