ADVANTX LCV+
FDA 510(k) clearance K960575 · decided 1996-05-07
Clearance details
- K-number
- K960575
- Device name
- ADVANTX LCV+
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-02-12
- Decision date
- 1996-05-07
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- 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 |
|---|---|---|
| GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 410 recall (Z-0021-2014) | GE Healthcare, LLC | 2013-10-17 |
| Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagn recall (Z-0616-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic recall (Z-2359-2008) | GE Healthcare | 2008-09-21 |
| Advantx-E is an angiographic X-Ray system. recall (Z-2038-2008) | GE Healthcare | 2008-09-16 |