Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
FDA 510(k) clearance K153119 · decided 2016-03-14
Clearance details
- K-number
- K153119
- Device name
- Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
- Applicant
- Summit Industries, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-10-29
- Decision date
- 2016-03-14
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.