FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RAY TV SYSTEM SONIAL VISION G4
K Number: K131075
·
Decision Mar 28, 2014
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
49
Review Days
345
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Basic Information
- Device Name
- X-RAY TV SYSTEM SONIAL VISION G4
- K Number
- K131075
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shimadzu Corp.
- Date Received
- April 17, 2013
- Decision Date
- March 28, 2014
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Shimadzu Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Mar 6, 2015 | Substantially Equivalent |
| K101039 | SHIMADZU COLLIMATOR R-300 | Sep 20, 2010 | Substantially Equivalent |
| K101036 | SHIMADZU COLLIMATOR R-20J | Aug 26, 2010 | Substantially Equivalent |
| K090578 | SHIMADZU COLLIMATOR R-30H | Nov 6, 2009 | Substantially Equivalent |
| K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | Jun 30, 2009 | Substantially Equivalent |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | May 14, 2008 | Substantially Equivalent |
| K072006 | DAR-9400F | Aug 31, 2007 | Substantially Equivalent |
| K071717 | GE OEC ALTITUDE | Jul 5, 2007 | Substantially Equivalent |
| K062360 | BRANSIST SAFIRE | Oct 5, 2006 | Substantially Equivalent |
| K050925 | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE | Jun 1, 2005 | Substantially Equivalent |