BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
FDA 510(k) clearance K110646 · decided 2011-10-12
Clearance details
- K-number
- K110646
- Device name
- BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
- Applicant
- Beam-Med, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-04
- Decision date
- 2011-10-12
- Days to decision
- 222 days
- Clearance type
- Abbreviated
- Product code
- MUA
- Device class
- 2
- Regulation number
- 892.1180
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Petach Tikva, IL
- Third-party review
- No
- Expedited review
- No
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| Bindex BI-2 (K211350) | Bone Index Finland , Ltd. | 2022-04-29 |
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| Bindex BI-2 (K161971) | Bone Index Finland , Ltd. | 2017-01-09 |
| Bindex BI-100 (K152020) | Bone Index Finland , Ltd. | 2016-05-13 |
| ACHILLES (K123238) | Ge Medical Systems China Co., Ltd. | 2013-02-25 |
| ACHILLES (K103633) | Ge Medical Systems China Co., Ltd. | 2011-05-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S005) | Beam-Med, Ltd. | 2003-11-17 |
| SUNLIGHT OMNISENSE BONE SONOMETER (P990035/S006) | Beam-Med, Ltd. | 2003-04-24 |
| SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S003) | Beam-Med, Ltd. | 2002-05-24 |
| SUNLIGHT OMNISENSE 7000S (P990035/S004) | Beam-Med, Ltd. | 2001-11-30 |
| SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER (P990035/S002) | Beam-Med, Ltd. | 2001-07-27 |
| OMNISENSE 7000S ULTRASOUND BONE SONOMETER (P990035/S001) | Beam-Med, Ltd. | 2001-06-21 |
| THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER (P990035) | Beam-Med, Ltd. | 2000-01-20 |