CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
FDA 510(k) clearance K042525 · decided 2004-10-01
Clearance details
- K-number
- K042525
- Device name
- CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2004-09-17
- Decision date
- 2004-10-01
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mount Prospect, IL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 203390 recall (Z-1485-2025) | GE Healthcare | 2025-03-28 |
| GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 203 recall (Z-1486-2025) | GE Healthcare | 2025-03-28 |
| Centricity Radiology RA600 recall (Z-1231-2022) | GE Healthcare, LLC | 2022-06-03 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002) | Ge Medical Systems Information Technologies | 2003-10-15 |
| COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001) | Ge Medical Systems Information Technologies | 2001-11-09 |
| COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016) | Ge Medical Systems Information Technologies | 2001-02-09 |
| MODEL 515 NEONATAL MONIOTR (P840037/S001) | Ge Medical Systems Information Technologies | 1986-11-19 |