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 Sep 28, 2021 as substantially equivalent to K181032 (Varian Medical Systems, Inc., 2018) and 5 other predicates after a 187-day review. Its family tree reaches back 13 generations to 1995. 1 later device descends from it.
- Decided
- Sep 28, 2021
- Review
- 187 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K926449 (1995). 76 ancestors in all, the oldest K854886 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 9 generations between
- 3 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 2 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 1 generation backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- This deviceK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 12 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 11 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 10 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 9 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 8 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 6 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 5 generations backK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 4 generations backK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- 2 generations backK170817 HalcyonVarian Medical Systems, Inc. · 2017
- 1 generation backK181032 HalcyonVarian Medical Systems, Inc. · 2018
- This deviceK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −12 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −11 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −10 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −9 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −8 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −7 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −6 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −5 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| −4 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| −3 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| −2 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| −1 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
| 0 (this device) | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (6)
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 |
|---|---|---|---|
| * | K181032 | HalcyonSummary page 5…ce Name Halcyon True Beam Trade/Proprietary Name Varian Medical Systems 510(k) Number Halcyon: K181032 True Beam: K171733 Date Cleared Halcyon: 9-May-18 True Beam: 12-Jul-17 Device Classificati… | 2018 |
| * | K171733 | TrueBeam, TrueBeam STx, EdgeSummary page 5…Halcyon True Beam Trade/Proprietary Name Varian Medical Systems 510(k) Number Halcyon: K181032 True Beam: K171733 Date Cleared Halcyon: 9-May-18 True Beam: 12-Jul-17 Device Classification: Class II Produc… | 2017 |
| * | K142420 | Patient Positioning DevicesSummary page 5…Date Cleared Device Manufacturer number IMPACT Head ExaFix-5 Macromedics K142420 Base Plate IMPACT Tilting Head Exatilt Macromedics K142420 27-Mar-2015 Base Plate IMPACT… | 2015 |
| * | K191158 | The AIO SolutionSummary page 6…(K) number Date Cleared Device Manufacturer IMPACT Sigma All in One Orfit K191158 6-Aug-2019 Board (AIO) Solution IMPACT SBRT System - Meticule Panace… | 2019 |
| * | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Summary page 6…ared Device Manufacturer SBRT System - Civco Medical Body Pro Lok K153026 25-May-2016 Meticule Solutions… | 2016 |
| * | K131795 | Nanor and Efficast/Nanor Hybrid Thermoplastic MaterialsSummary page 7…Device Manufacturer NANOR IMPACT SRS Hybrid System - Orfit K131795 26-Sep-13 Thermoplastic Mastereo Materials V. Device Descripti… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222762 | Siddharth-II;Impact | 2023 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 29 of the 76 ancestors have a recall of any class.
- Of its descendants, K222762 (Panacea Medical Technologies Pvt., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181032.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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.
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/K210894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210894: Siddharth-II; Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210894
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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