FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FDR Visionary Suite
K Number: K152294
·
Decision Jul 15, 2016
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
9
Review Days
337
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Basic Information
- Device Name
- FDR Visionary Suite
- K Number
- K152294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shimadzu Corporation
- Date Received
- August 13, 2015
- Decision Date
- July 15, 2016
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Shimadzu Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252099 | Trinias | Mar 24, 2026 | Substantially Equivalent |
| K233719 | FDR Visionary Suite | Mar 28, 2024 | Substantially Equivalent |
| K233722 | RADspeed Pro | Feb 23, 2024 | Substantially Equivalent |
| K191877 | FLUOROspeed | Aug 5, 2019 | Substantially Equivalent |
| K190373 | SonialVision G4 | Mar 15, 2019 | Substantially Equivalent |
| K173517 | RADspeed fit | Mar 30, 2018 | Substantially Equivalent |
| K152244 | RADspeed Pro | Jun 20, 2016 | Substantially Equivalent |
| K123508 | TRINIAS | Feb 26, 2014 | Substantially Equivalent |