FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SunCHECK
K Number: K170307
·
Decision Oct 25, 2017
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
9
Review Days
266
Basic Information
- Device Name
- SunCHECK
- K Number
- K170307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SUN NUCLEAR CORPORATION
- Date Received
- February 1, 2017
- Decision Date
- October 25, 2017
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by SUN NUCLEAR CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K142617 | ArcCHECK | Nov 20, 2015 | Substantially Equivalent |
| K150848 | Dose Calculator | May 20, 2015 | Substantially Equivalent |
| K142431 | WaterProof PROFILER | Dec 5, 2014 | Substantially Equivalent |
| K142142 | QUALITY REPORTS | Dec 5, 2014 | Substantially Equivalent |
| K141800 | PERFRACTION | Sep 26, 2014 | Substantially Equivalent |
| K131862 | 3DVH | Aug 21, 2013 | Substantially Equivalent |
| K131466 | MAPCHECK2, ARCCHECK | Aug 20, 2013 | Substantially Equivalent |
| K131704 | EPIDOSE | Aug 5, 2013 | Substantially Equivalent |