510(k) · Cleared
ClearedSiddharth-II;Impact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panacea Medical Technologies Pvt., Ltd. · IYE Accelerator, Linear, Medical
Cleared on Jun 8, 2023 as substantially equivalent to K210894 (Panacea Medical Technologies Pvt., Ltd., 2021) after a 268-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Jun 8, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K926449 (1995). 77 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 14 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 10 generations between
- 3 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 2 generations backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- 1 generation backK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- This deviceK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 13 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 12 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 11 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 10 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 9 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 8 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 7 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 6 generations backK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 5 generations backK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 3 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 2 generations backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- 1 generation backK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- This deviceK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −13 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −12 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −11 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −10 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −9 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −8 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −7 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −6 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| −5 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| −4 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| −3 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| −2 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
| −1 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| 0 (this device) | K222762 | Siddharth-II;Impact | Panacea Medical Technologies Pvt., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 29 of the 77 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lesions, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients. Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes: - acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy…
Read the full statement (122 words)
SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lesions, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients.
Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes:
- acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy system.
- beam data analysis according to international therapy dosimetry protocols
- acquisition, formatting and transfer of basic data to treatment planning systems
The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222762 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222762: Siddharth-II;Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222762
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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