AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
FDA 510(k) clearance K081963 · decided 2008-07-25
Clearance details
- K-number
- K081963
- Device name
- AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
- Applicant
- Agfa Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-07-10
- Decision date
- 2008-07-25
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenville, SC, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.