FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
K Number: K983879
·
Decision Mar 22, 1999
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
39
Review Days
140
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
- K Number
- K983879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aloka Co., Ltd.
- Date Received
- November 2, 1998
- Decision Date
- March 22, 1999
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 19, 2008 | 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 |