LCV+ VERSION 2
FDA 510(k) clearance K993037 · decided 2000-02-14
Clearance details
- K-number
- K993037
- Device name
- LCV+ VERSION 2
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-09
- Decision date
- 2000-02-14
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 410 recall (Z-0021-2014) | GE Healthcare, LLC | 2013-10-17 |
| Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The sys recall (Z-0392-2011) | GE Healthcare, LLC | 2010-11-16 |
| 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 |
| Innova 2000; The principle system components include a C-arm, image acquisition, processin recall (Z-2435-2008) | GE Healthcare | 2008-09-20 |
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 |