ADVANTAGE SIM MD
FDA 510(k) clearance K052345 · decided 2005-09-14
Clearance details
- K-number
- K052345
- Device name
- ADVANTAGE SIM MD
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2005-08-26
- Decision date
- 2005-09-14
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KPQ
- Device class
- 2
- Regulation number
- 892.5840
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GE Healthcare
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION (K132944) | Ge Hungary Kft | 2014-03-14 |
| ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (K132045) | Ge Hungary Kft | 2013-09-04 |
| RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (K101038) | Acceletronics Digital Imaging, LLC | 2010-08-17 |
| 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 |
| SIMULIX EVOLUTION (K033470) | Nucletron Corporation | 2004-02-04 |
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |
| EXOMIO, MODEL 2.0 SP1 (K032550) | Medcom GmbH | 2003-09-25 |
| ACUITY RADIATION THERAPY SIMULATOR (K023052) | Varian Medical Systems, Inc. | 2002-10-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7 recall (Z-0754-2013) | GE Healthcare, LLC | 2013-01-30 |
| 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 |
| AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepar recall (Z-1718-2009) | GE Medical Systems, LLC | 2009-08-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |