HORIZON MEDICAL IMAGING
FDA 510(k) clearance K043146 · decided 2005-01-04
Clearance details
- K-number
- K043146
- Device name
- HORIZON MEDICAL IMAGING
- Applicant
- Mckesson Medical Imaging Company
- Decision
- Substantially Equivalent
- Date received
- 2004-11-15
- Decision date
- 2005-01-04
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Richmond, B.C., CA
- Third-party review
- Yes
- Expedited review
- No
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