510(k) · Cleared
ClearedNOVAC 11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Radiant Technology S.P.A. · IYE Accelerator, Linear, Medical
Cleared on Apr 19, 2012 as substantially equivalent to K990209 (Hitesys S.P.A., 2000) and 1 other predicate after a 254-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- Apr 19, 2012
- Review
- 254 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852907 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK852907 Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985
- 2 generations backK981112 MobetronIntraop Medical, Inc. · 1998 · Recalled
- 1 generation backK990209 NOVAC7Hitesys S.P.A. · 2000
- This deviceK112286 NOVAC 11New Radiant Technology S.P.A. · 2012
- Descendant · cites it directly · 1 of its ownK172961 Liac HWLSit Sordina Iort Technologies Spa · 2018
- Descendant · 2 generations on · 0 of its ownK182374 LIAC SSit Sordina Iort Technologies Spa · 2019
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 |
|---|---|---|---|---|---|
| −3 | K852907 | Siemens Mevatron ME | Siemens Medical Laboratories, Inc. | 1985 | — |
| −2 | K981112 | Mobetron | Intraop Medical, Inc. | 1998 | 1 |
| −1 | K990209 | NOVAC7 | Hitesys S.P.A. | 2000 | — |
| 0 (this device) | K112286 | NOVAC 11 | New Radiant Technology S.P.A. | 2012 | — |
| +1 | K172961 | Liac HWL | Sit Sordina Iort Technologies Spa | 2018 | — |
| +2 | K182374 | LIAC S | Sit Sordina Iort Technologies Spa | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K990209 | NOVAC7Summary page 2…N 2.3. Predicate Devices NOVAC Ills substantially equivalent to the following devices: HyteMsiS.p.A. NOVAC7 K990209 lntrao Medical Inc. MOBETRON K981 112 NOVAC I I and its predicate devices are elect… | 2000 |
| * | K981112 | MobetronSummary page 2…ing devices: HyteMsiS.p.A. NOVAC7 K990209 lntrao Medical Inc. MOBETRON K981 112 NOVAC I I and its predicate devices are electron linear accelerators used for radiation therapy (IORT) during surgical procedure… | 1998 |
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 |
|---|---|---|---|
| K172961 | Liac HWL | 2018 | 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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K172961 (Sit Sordina Iort Technologies Spa, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 NOVAC II is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC II is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy; Applicators direct the electron beam to the involved surgical area of interest.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112286 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112286: NOVAC 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112286
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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