FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K Number: K083254
·
Decision Dec 19, 2008
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
39
Review Days
45
Basic Information
- Device Name
- ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
- K Number
- K083254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ALOKA CO., LTD.
- Date Received
- November 4, 2008
- Decision Date
- December 19, 2008
- 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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Other Clearances by ALOKA CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K111227 | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | May 13, 2011 | Substantially Equivalent |
| K110207 | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 17, 2011 | Substantially Equivalent |
| K093488 | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 20, 2009 | Substantially Equivalent |
| K081843 | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 | Jul 15, 2008 | Substantially Equivalent |
| K080176 | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 29, 2008 | Substantially Equivalent |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | Aug 30, 2007 | Substantially Equivalent |
| K060059 | ALOKA SD-3500 ULTRASOUND SYSTEM | Jan 13, 2006 | Substantially Equivalent |
| K043196 | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | Nov 30, 2004 | Substantially Equivalent |
| K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | Mar 26, 2004 | Substantially Equivalent |
| K033311 | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM | Oct 29, 2003 | Substantially Equivalent |