FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
K Number: K012239
·
Decision Aug 10, 2001
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
11
Review Days
24
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Basic Information
- Device Name
- MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM
- K Number
- K012239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Medical Corp.
- Date Received
- July 17, 2001
- Decision Date
- August 10, 2001
- 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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FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| K042501 | ETG-4000 OPTICAL TOPOGRAPHY SYSTEM | Oct 12, 2004 | Substantially Equivalent |
| K013722 | MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 11, 2002 | Substantially Equivalent |
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 6, 2002 | Substantially Equivalent |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | May 30, 2001 | Substantially Equivalent |
| K926209 | EUB-555 | Jun 3, 1994 | Substantially Equivalent |
| K910268 | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T | Apr 15, 1991 | Substantially Equivalent |
| K827377 | MODEL LS 3000 LINEAR SCANNER | Jul 13, 1982 | Substantially Equivalent |