510(k) K103633
- Device
- ACHILLES
- Applicant
- GE MEDICAL SYSTEMS CHINA CO., LTD.
- 510(k) number
- K103633
- Product code
- MUA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-11
- Date received
- 2010-12-13
- Regulation
- 892.1180
- Classification name
- Bone Sonometer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRIS PAULIK
- Address
- # 19 Changjiang Rd. National Hi-Tech Dev. Zone Wuxi, Jiangsu Province CN 214028 214028
FDA Registration Numbers#
- 3005944888
- 9710602
- 3006701790
- 3015973732
- 3013328880
- 3004977335
Source Documents#
Other 510(k) Records For Product Code MUA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211350 | Bindex BI-2 | Bone Index Finland , Ltd. | 2022-04-29 |
| K202514 | EchoS Family | Echolight S.P.A | 2021-02-25 |
| K180516 | EchoS | Echolight S.P.A | 2018-10-19 |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | 2017-04-05 |
| K161971 | Bindex BI-2 | Bone Index Finland , Ltd. | 2017-01-09 |
| K152020 | Bindex BI-100 | Bone Index Finland , Ltd. | 2016-05-13 |
| K123238 | ACHILLES | Ge Medical Systems China Co., Ltd. | 2013-02-25 |
| K110646 | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER | Beam-Med, Ltd. | 2011-10-12 |
Legacy Summary#
summary
FDA Review#
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