FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAR-8000I
K Number: K052076
·
Decision Sep 2, 2005
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
90
Review Days
32
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Basic Information
- Device Name
- DAR-8000I
- K Number
- K052076
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Medical Systems
- Date Received
- August 1, 2005
- Decision Date
- September 2, 2005
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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Other Clearances by Shimadzu Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | Dec 15, 2008 | Substantially Equivalent |
| 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 |
| 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 |