FDA Product Code
FDA Product Code MUA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1180
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211350 | Bindex BI-2 | Bone Index Finland , Ltd. | 2022-04-29 | Traditional | PDF ↗ |
| K202514 | EchoS Family | Echolight S.P.A | 2021-02-25 | Traditional | PDF ↗ |
| K180516 | EchoS | Echolight S.P.A | 2018-10-19 | Traditional | PDF ↗ |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017-04-05 | Traditional | PDF ↗ |
| K161971 | Bindex BI-2 | Bone Index Finland , Ltd. | 2017-01-09 | Abbreviated | PDF ↗ |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | 2016-05-13 | Abbreviated | PDF ↗ |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2013-02-25 | Traditional | PDF ↗ |
| K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | 2011-10-12 | Abbreviated | PDF ↗ |
| K103633 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2011-05-11 | Traditional | PDF ↗ |
Product code MUA · Class II · Radiology. Data: openFDA.