510(k) · Cleared
ClearedRfa-300, Lda Utility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scanditronix Medical AB · IYE Accelerator, Linear, Medical
Cleared on Jan 3, 1997 as substantially equivalent to K934303 (Scanditronix, Inc., 1994) after a 267-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 3, 1997
- Review
- 267 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934303 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934303 RFA A-300Scanditronix, Inc. · 1994
- This deviceK961400 Rfa-300, Lda UtilityScanditronix Medical AB · 1997
- Descendant · cites it directly · 1 of its ownK011763 OmnidosScanditronix Medical AB · 2001
- Descendant · 2 generations on · 0 of its ownK092018 Omnipro InclineIba Dosimetry GmbH · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934303 | RFA A-300 | Scanditronix, Inc. | 1994 | — |
| 0 (this device) | K961400 | Rfa-300, Lda Utility | Scanditronix Medical AB | 1997 | — |
| +1 | K011763 | Omnidos | Scanditronix Medical AB | 2001 | — |
| +2 | K092018 | Omnipro Incline | Iba Dosimetry GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934303 | RFA A-300Summary page 1…herapy system, §892,5750; and X-ray radiation therapy system, §892,5900. 3) Identification of predicate = RFA-300 (Scanditronix Medical AB, or legally marketed device: K934303 / S1) , Wellhofer WP600 (Medical Physics instrumentation, K882770) and Wellhofer MDA ( Medical Physics instrumentation). @ Descr… | 1994 |
| Kept off the family tree | K882770 | Wellhofer WP600 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…2,5900. 3) Identification of predicate = RFA-300 (Scanditronix Medical AB, or legally marketed device: K934303 / S1) , Wellhofer WP600 (Medical Physics instrumentation, K882770) and Wellhofer MDA ( Medical Physics instrumentation). @ Description of the devise: The Scanditronix Medical RFA-300, LDA Utili… | |
| * | — | Wellhofer MDA Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011763 | Omnidos | 2001 | 1 |
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?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor.
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/K961400 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961400: Rfa-300, Lda Utility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961400
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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