510(k) · Cleared
ClearedVeridose V (Five), Model Number 37-705
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victoreen, Inc. · JAD System, Therapeutic, X-Ray
Cleared on Jul 21, 1997 as substantially equivalent to K912249 (Theta Systems, Inc., 1991) after a 223-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 21, 1997
- Review
- 223 days
- Class
- Class II
- Product code
- JAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912249 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912249 Patient Dose MonitorTheta Systems, Inc. · 1991
- This deviceK964952 Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912249 | Patient Dose Monitor | Theta Systems, Inc. | 1991 | — |
| 0 (this device) | K964952 | Veridose V (Five), Model Number 37-705 | Victoreen, Inc. | 1997 | — |
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 JAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAD device
- #1 K241174 INTRABEAM (700); And accessories (INTRABEAM…score 11.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K912249 | Patient Dose MonitorSummary page 1…e Name: Veridose V (five), Model number 37-705 Classification Name: X-ray Radiation Therapy System Predicate Device: Patient Dose Monitor, Theta Model #526, 510(k) #K912249/A Intended Use: (Function): This device provides integrated dose and dose rate readout capabilities for radiation sensing diod… | 1991 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K912249.
How does its category compare?
All JAD devicesJAD System, Therapeutic, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAD
114in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAD
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAD
1in 2025
MAUDE reports naming product code JAD, 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 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 106 | 2 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 3 |
| 2012 | 2 | — | 3 | 4 |
| 2013 | 5 | 114 | 0 | 12 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Veridose V (Five) - Model Number 37-705 is used to provide integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy.
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/K964952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964952: Veridose V (Five), Model Number 37-705.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964952
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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