FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K Number: K090268
·
Decision Jun 30, 2009
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
49
Review Days
147
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
- SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
- K Number
- K090268
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Corp.
- Date Received
- February 3, 2009
- Decision Date
- June 30, 2009
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZL), ordered by most recent decision date.
Portable DR Imaging System
FDA 510(k)
FDA Class 2
·Radiology
RAYMO Mobile X-ray System (Model: RAYMO)
FDA 510(k)
FDA Class 2
·Radiology
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
FDA 510(k)
FDA Class 2
·Radiology
Airbile-100
FDA 510(k)
FDA Class 2
·Radiology
Mobile X-ray unit (!M1)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Shimadzu Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Mar 6, 2015 | Substantially Equivalent |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Mar 28, 2014 | 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 |
| 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 |