FDA product code KPQ: System, Simulation, Radiation Therapy
KPQ is the FDA product code for system, simulation, radiation therapy. It is a Class II device, regulated under 21 CFR 892.5840 and reviewed by the Radiology panel. FDA has cleared 70 510(k) submissions under KPQ, from 46 different applicants. The average 510(k) review took 109 days (median 88). FDA has posted 13 recalls for KPQ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Simulation, Radiation Therapy |
| Device class | Class II |
| Regulation | 21 CFR 892.5840 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KPQ clearance
Top KPQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Varian Assoc., Inc. | 6 | 2000-02-16 |
| Varian Medical Systems, Inc. | 4 | 2003-12-30 |
| Nucletron Corporation | 3 | 2009-06-15 |
| Siemens Medical Solutions USA, Inc. | 3 | 1996-11-29 |
| Computerized Medical Systems, Inc. | 3 | 1992-11-02 |
41 more applicants have KPQ clearances. See the full list in Caduvo.
Most recent KPQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132944 | Ge Hungary Kft | ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION | 2014-03-14 | 176 |
| K132045 | Ge Hungary Kft | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS | 2013-09-04 | 64 |
| K101038 | Acceletronics Digital Imaging, LLC | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER | 2010-08-17 | 125 |
| K090706 | Nucletron Corporation | ONCENTRA SIMULATION 2.3 | 2009-06-15 | 90 |
| K083591 | Ikoetech, LLC | IKOENGELO, VERSION 2 | 2008-12-29 | 25 |
Recalls for KPQ devices
13 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-10-10.
Frequently asked questions
What is FDA product code KPQ?
KPQ is the FDA product code for system, simulation, radiation therapy. It is a Class II device, regulated under 21 CFR 892.5840 and reviewed by the Radiology panel.
What device class is KPQ?
Class II, regulation 21 CFR 892.5840. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPQ?
Across 70 cleared submissions the average was 109 days from receipt to decision (median 88).
Which companies have the most KPQ clearances?
Varian Assoc., Inc. (6); Varian Medical Systems, Inc. (4); Nucletron Corporation (3); Siemens Medical Solutions USA, Inc. (3); Computerized Medical Systems, Inc. (3).
Have KPQ devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2014-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KPQ
- Run a recall and safety report across every KPQ manufacturer
- Watch product code KPQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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