Bindex BI-2
FDA 510(k) clearance K161971 · decided 2017-01-09
Clearance details
- K-number
- K161971
- Device name
- Bindex BI-2
- Applicant
- Bone Index Finland , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-18
- Decision date
- 2017-01-09
- Days to decision
- 175 days
- Clearance type
- Abbreviated
- Product code
- MUA
- Device class
- 2
- Regulation number
- 892.1180
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kuopio, FI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bindex BI-2 (K211350) | Bone Index Finland , Ltd. | 2022-04-29 |
| EchoS Family (K202514) | Echolight S.P.A | 2021-02-25 |
| EchoS (K180516) | Echolight S.P.A | 2018-10-19 |
| UltraScan 650 (K161919) | Cyberlogic, Inc. | 2017-04-05 |
| Bindex BI-100 (K152020) | Bone Index Finland , Ltd. | 2016-05-13 |
| ACHILLES (K123238) | Ge Medical Systems China Co., Ltd. | 2013-02-25 |
| BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (K110646) | Beam-Med, Ltd. | 2011-10-12 |
| ACHILLES (K103633) | Ge Medical Systems China Co., Ltd. | 2011-05-11 |
Recalls involving this device
No recalls on record reference this clearance.