FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
K Number: K053154
·
Decision Dec 16, 2005
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
12
Review Days
32
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Basic Information
- Device Name
- MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
- K Number
- K053154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pie Medical
- Date Received
- November 14, 2005
- Decision Date
- December 16, 2005
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
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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| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | Mar 1, 2001 | Substantially Equivalent |
| K003292 | 260 CORVUS | Jan 5, 2001 | Substantially Equivalent |
| K002357 | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS | Nov 9, 2000 | Substantially Equivalent |