FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K Number: K053069
·
Decision Nov 16, 2005
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
23
Review Days
15
Basic Information
- Device Name
- SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
- K Number
- K053069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SONOSITE,INC.
- Date Received
- November 1, 2005
- Decision Date
- November 16, 2005
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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|---|---|---|---|
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| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | Oct 2, 2009 | Substantially Equivalent |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Aug 25, 2008 | Substantially Equivalent |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | May 8, 2007 | Substantially Equivalent |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | Aug 11, 2005 | Substantially Equivalent |
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Jan 12, 2005 | Substantially Equivalent |