SONOSITE MAXX SERIES ULTRASOUND SYSTEM
FDA 510(k) clearance K082098 · decided 2008-08-25
Clearance details
- K-number
- K082098
- Device name
- SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- Applicant
- Sonosite,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-25
- Decision date
- 2008-08-25
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound recall (Z-0057-2012) | Sonosite, Inc. | 2011-10-18 |
| PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the st recall (Z-2116-2010) | Sonosite, Inc. | 2010-08-02 |