ADVANTAGE SIM
FDA 510(k) clearance K951830 · decided 1995-11-13
Clearance details
- K-number
- K951830
- Device name
- ADVANTAGE SIM
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-20
- Decision date
- 1995-11-13
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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| ONCENTRA SIMULATION 2.3 (K090706) | Nucletron Corporation | 2009-06-15 |
| IKOENGELO, VERSION 2 (K083591) | Ikoetech, LLC | 2008-12-29 |
| INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (K072445) | Nucletron Corp. | 2007-09-14 |
| IKOENGELO (K061006) | Ikoetech, LLC | 2006-06-05 |
| SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (K052361) | Nucletron Corporation | 2005-10-24 |
| ADVANTAGE SIM MD (K052345) | GE Healthcare | 2005-09-14 |
| SIMULIX EVOLUTION (K033470) | Nucletron Corporation | 2004-02-04 |
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim recall (Z-1473-2011) | GE Healthcare, LLC | 2011-03-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |