INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
FDA 510(k) clearance K024200 · decided 2003-01-16
Clearance details
- K-number
- K024200
- Device name
- INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-20
- Decision date
- 2003-01-16
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Innova 2000 The principle system components include a C-arm, image acquisition, processing recall (Z-0393-2011) | GE Healthcare, LLC | 2010-11-16 |
| Innova 2000, manufactured by GE Medical Systems, SCS recall (Z-2238-2010) | GE Healthcare, LLC | 2010-08-19 |
| Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system recall (Z-0620-2010) | GE Medical Systems, LLC | 2010-01-13 |
| GE, Innova 2000 The principle system components include a C-arm, image acquisition, proces recall (Z-2240-2009) | GE Medical Systems, LLC | 2009-09-24 |
| Innova 2000; The principle system components include a C-arm, image acquisition, processin recall (Z-2435-2008) | GE Healthcare | 2008-09-20 |
| Innova 2000's principle system components include a C-arm, image acquisition, processing a recall (Z-2042-2008) | GE Healthcare | 2008-09-16 |
| GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile v recall (Z-0896-06) | GE Healthcare | 2006-05-24 |
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 |