CENTRICITY AW SUITE OPTION
FDA 510(k) clearance K061372 · decided 2006-05-30
Clearance details
- K-number
- K061372
- Device name
- CENTRICITY AW SUITE OPTION
- Applicant
- Ge Healthcare Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2006-05-17
- Decision date
- 2006-05-30
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Barrington, IL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Modu recall (Z-2183-2008) | GE Healthcare Integrated IT Solutions | 2008-09-16 |
| GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Work recall (Z-1825-2008) | GE Healthcare Integrated IT Solutions | 2008-09-02 |