MCKESSON RADIOLOGY
FDA 510(k) clearance K140909 · decided 2014-07-02
Clearance details
- K-number
- K140909
- Device name
- MCKESSON RADIOLOGY
- Applicant
- Mckesson Medical Imaging Company
- Decision
- Substantially Equivalent
- Date received
- 2014-04-09
- Decision date
- 2014-07-02
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Change Healthcare Radiology Solutions software version 14.2.2 recall (Z-0030-2026) | CHANGE HEALTHCARE CANADA COMPANY | 2025-10-02 |
| Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical imag recall (Z-0237-2024) | CHANGE HEALTHCARE CANADA COMPANY | 2023-11-06 |