AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
FDA 510(k) clearance K071162 · decided 2007-05-08
Clearance details
- K-number
- K071162
- Device name
- AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
- Applicant
- Agfa Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-26
- Decision date
- 2007-05-08
- Days to decision
- 12 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
| Record | Firm | Date |
|---|---|---|
| NX is the radiographer's image identification and quality control tool. It offers a broad recall (Z-2137-2011) | AGFA Corp. | 2011-05-04 |
| 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Comput recall (Z-2100-2010) | AGFA Corp. | 2010-07-26 |