510(k) K101038
- Device
- RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
- Applicant
- ACCELETRONICS DIGITAL IMAGING, LLC.
- 510(k) number
- K101038
- Product code
- KPQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-17
- Date received
- 2010-04-14
- Regulation
- 892.5840
- Classification name
- System, Simulation, Radiation Therapy
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE SCHWARZ
- Address
- 602 Gordon Dr. Exton PA US 19341 19341
FDA Registration Numbers#
- 9611343
- 3007545404
- 9617016
- 3015232217
- 1123169
- 2916710
- 1219183
Source Documents#
Other 510(k) Records For Product Code KPQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132944 | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | Ge Hungary Kft | 2014-03-14 |
| K132045 | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | Ge Hungary Kft | 2013-09-04 |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | 2009-06-15 |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | 2008-12-29 |
| K072445 | INTEGRATED BRACHYTHERAPY UNIT - DIGITAL | Nucletron Corp. | 2007-09-14 |
| K061006 | IKOENGELO | Ikoetech, LLC | 2006-06-05 |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | 2005-10-24 |
| K052345 | ADVANTAGE SIM MD | GE Healthcare | 2005-09-14 |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | 2004-02-04 |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | 2003-12-30 |
| K032550 | EXOMIO, MODEL 2.0 SP1 | Medcom GmbH | 2003-09-25 |
| K023052 | ACUITY RADIATION THERAPY SIMULATOR | Varian Medical Systems, Inc. | 2002-10-11 |
| K022219 | EXOMIO, MODEL 1.1 | Medcom GmbH | 2002-10-07 |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | 2002-07-29 |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | Impac Medical Systems, Inc. | 2001-11-07 |
Legacy Summary#
summary
FDA Review#
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