FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
K Number: K102256
·
Decision Oct 5, 2010
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
12
Review Days
56
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Basic Information
- Device Name
- GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
- K Number
- K102256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems China Co., Ltd.
- Date Received
- August 10, 2010
- Decision Date
- October 5, 2010
- 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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FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ge Medical Systems China Co., Ltd.
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|---|---|---|---|
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| K133576 | MONITOR B40 | Feb 21, 2014 | Substantially Equivalent |
| K130584 | MONITOR B40 | Jun 26, 2013 | Substantially Equivalent |
| K122253 | PROCARE MONITOR B20 | Mar 22, 2013 | Substantially Equivalent |
| K123238 | ACHILLES | Feb 25, 2013 | Substantially Equivalent |
| K120598 | PROCARE MONITOR B40 | Jul 19, 2012 | Substantially Equivalent |
| K103633 | ACHILLES | May 11, 2011 | Substantially Equivalent |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 | Substantially Equivalent |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 | Substantially Equivalent |