510(k) · Cleared
ClearedNOVAC7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitesys S.P.A. · IYE Accelerator, Linear, Medical
Cleared on Jun 22, 2000 as substantially equivalent to K981112 (Intraop Medical, Inc., 1998) after a 518-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- Jun 22, 2000
- Review
- 518 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852907 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK852907 Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985
- 1 generation backK981112 MobetronIntraop Medical, Inc. · 1998 · Recalled
- This deviceK990209 NOVAC7Hitesys S.P.A. · 2000
- Descendant · cites it directly · 2 of its ownK112286 NOVAC 11New Radiant Technology S.P.A. · 2012
- Descendant · 2 generations on · 1 of its ownK172961 Liac HWLSit Sordina Iort Technologies Spa · 2018
- Descendant · 3 generations on · 0 of its ownK182374 LIAC SSit Sordina Iort Technologies Spa · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852907 | Siemens Mevatron ME | Siemens Medical Laboratories, Inc. | 1985 | — |
| −1 | K981112 | Mobetron | Intraop Medical, Inc. | 1998 | 1 |
| 0 (this device) | K990209 | NOVAC7 | Hitesys S.P.A. | 2000 | — |
| +1 | K112286 | NOVAC 11 | New Radiant Technology S.P.A. | 2012 | — |
| +2 | K172961 | Liac HWL | Sit Sordina Iort Technologies Spa | 2018 | — |
| +3 | K182374 | LIAC S | Sit Sordina Iort Technologies Spa | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K981112 | MobetronSummary page 1…rietary and Trade Name: NOVAC7 Classification Name: Radiation Therapy, Charged-Particle, Medical System per 21 CFR 892.5050 3. Predicate Device: MOBETRON, 510(k) number K981112 ‘ Intraop Medical Inc. Santa Clara, CA 95054 4. Description of Device: The NOVACT is an electron accelerator for intraoperative… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112286 | NOVAC 11 | 2012 | 2 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K112286 (New Radiant Technology S.P.A., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K981112.
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 NOVACT is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Know as intraoperative radiation therapy (IORT), this technique allow delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC7 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 surgical area of interest.
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/K990209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990209: NOVAC7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990209
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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