QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
FDA 510(k) clearance K003264 · decided 2000-12-21
Clearance details
- K-number
- K003264
- Device name
- QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
- Applicant
- Ge Medical Systems F.I. Haifa
- Decision
- Substantially Equivalent
- Date received
- 2000-10-18
- Decision date
- 2000-12-21
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.