AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
FDA 510(k) clearance K090672 · decided 2009-05-18
Clearance details
- K-number
- K090672
- Device name
- AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
- Applicant
- Agfa Healthcare N.V.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-13
- Decision date
- 2009-05-18
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mortsel, BE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography S recall (Z-1889-2009) | AGFA Corp. | 2009-09-02 |