SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
FDA 510(k) clearance K053069 · decided 2005-11-16
Clearance details
- K-number
- K053069
- Device name
- SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
- Applicant
- Sonosite,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-01
- Decision date
- 2005-11-16
- Days to decision
- 15 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
+ Add to Predicate Builder ◉ Watch Sonosite
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |
| MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer recall (Z-0661-2007) | Sonosite, Inc. | 2007-03-29 |