REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
FDA 510(k) clearance K012389 · decided 2001-08-10
Clearance details
- K-number
- K012389
- Device name
- REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-27
- Decision date
- 2001-08-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital recall (Z-1989-2014) | GE Healthcare, LLC | 2014-07-02 |
| GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grand recall (Z-1789-2012) | General Electric Med Systems LLC | 2012-06-08 |
| GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505. GE Healthcare, 3000 North Gr recall (Z-0527-2010) | GE Medical Systems, LLC | 2009-12-16 |
| Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic recall (Z-0157-03) | General Electric Med Systems | 2003-02-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011) | Ge Medical Systems, Inc. | 2012-10-10 |
| FETAL ACOUSTIC STIMULATOR (P870025/S010) | Ge Medical Systems, Inc. | 2011-10-12 |
| FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009) | Ge Medical Systems, Inc. | 2010-04-23 |
| FETAL ACOUSTIC STIMULATOR (P870025/S008) | Ge Medical Systems, Inc. | 2006-03-02 |
| COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007) | Ge Medical Systems, Inc. | 2005-03-24 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006) | Ge Medical Systems, Inc. | 2001-11-09 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005) | Ge Medical Systems, Inc. | 1996-07-17 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004) | Ge Medical Systems, Inc. | 1996-02-01 |