510(k) · Cleared
ClearedRad II Simulator, Rad II KV Imager, Dual Rad II KV Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acceletronics Digital Imaging, LLC · KPQ System, Simulation, Radiation Therapy
Cleared on Aug 17, 2010 as substantially equivalent to K040192 (Varian Medical Systems, Inc., 2004) and 4 other predicates after a 125-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 17, 2010
- Review
- 125 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K963624 (1996). 6 ancestors in all, the oldest K834281 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 2 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 1 generation backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- This deviceK101038 Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −2 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −1 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| 0 (this device) | K101038 | Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager | Acceletronics Digital Imaging, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040192 | ON-Board Imager DeviceSummary page 1…Product Code: KPQ 3. Predicate Devices to claim substantial equivalence: A) Varian Medical Systems On-Board lmager K040192 B) Varian Medical Systems Portal Vision K003636 C) Elekta Synergy… | 2004 |
| * | K003636 | PortalvisionSummary page 1…al equivalence: A) Varian Medical Systems On-Board lmager K040192 B) Varian Medical Systems Portal Vision K003636 C) Elekta Synergy K032996 0) Oldelft Simulux-HP… | 2001 |
| * | K032996 | Elekta Synergy SystemSummary page 1…K040192 B) Varian Medical Systems Portal Vision K003636 C) Elekta Synergy K032996 0) Oldelft Simulux-HP K9461 28 E) Haynes Radiation Ltd., Inc. RAID 1ISi… | 2003 |
| * | K946128 | Simulix-HPSummary page 1…K003636 C) Elekta Synergy K032996 0) Oldelft Simulux-HP K9461 28 E) Haynes Radiation Ltd., Inc. RAID 1ISimulator K834281 4. Description of the device: The RAID 11K… | 1995 |
| * | K834281 | Rad II SimulatorSummary page 1…K032996 0) Oldelft Simulux-HP K9461 28 E) Haynes Radiation Ltd., Inc. RAID 1ISimulator K834281 4. Description of the device: The RAID 11KV Imaging device is mounted directly to the head of a Linear Accelerator… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040192.
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Both the RAID II KV Imager and RAID 1ISimulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer. 2. Both the RAID II KV Imager and RAID 1ISimulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices. 3. The RAID 11KV Imager is an "On Board Imager" intended for usage as a patient positioning…
Read the full statement (178 words)
1. Both the RAID II KV Imager and RAID 1ISimulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
2. Both the RAID II KV Imager and RAID 1ISimulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
3. The RAID 11KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
4. The RAID II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
5. The RAID 11Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
6. The RAD 11Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101038: Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026