FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K Number: K082224
·
Decision Dec 15, 2008
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
90
Review Days
131
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Basic Information
- Device Name
- DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K Number
- K082224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shimadzu Medical Systems
- Date Received
- August 6, 2008
- Decision Date
- December 15, 2008
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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Other Clearances by Shimadzu Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | Jan 9, 2008 | Substantially Equivalent |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jan 9, 2008 | Substantially Equivalent |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Jan 9, 2008 | Substantially Equivalent |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jul 27, 2006 | Substantially Equivalent |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | Jul 25, 2006 | Substantially Equivalent |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | Jul 14, 2006 | Substantially Equivalent |
| K052500 | DAR-8000F | Oct 17, 2005 | Substantially Equivalent |
| K052076 | DAR-8000I | Sep 2, 2005 | Substantially Equivalent |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Apr 1, 2005 | Substantially Equivalent |
| K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | Feb 12, 2001 | Substantially Equivalent |