510(k) · Cleared
ClearedCRC 15ULTRA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capintec, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 8, 2005 after a 48-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 8, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | CRC 35R Named without a submission number | |
| * | — | CRC 15R Named without a submission number | |
| * | — | Beta Counter Named without a submission number | |
| * | — | Caprac R Counter Named without a submission number |
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.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The CRC 15 Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiophamaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be…
Read the full statement (106 words)
The CRC 15 Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiophamaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052595: CRC 15ULTRA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052595
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026