# K210894: Siddharth-II; Impact

- Pathway: 510(k) (Traditional)
- Applicant: Panacea Medical Technologies Pvt., Ltd.
- Decided: Sep 28, 2021 after 187 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K926449 (1995). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181032: Halcyon, Varian Medical Systems, Inc. (2018) Summary page 5.
- K171733: TrueBeam, TrueBeam STx, Edge, Varian Medical Systems, Inc. (2017) Summary page 5.
- K142420: Patient Positioning Devices, Macromedics BV (2015) Summary page 5.
- K191158: The AIO Solution, Orfit Industries NV (2019) Summary page 6.
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement, Medtec, Inc. D/B/A Civco Medical Solutions (2016) Summary page 6.
- K131795: Nanor and Efficast/Nanor Hybrid Thermoplastic Materials, Orfit Industries NV (2013) Summary page 7.

## Most influential descendants
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K210894
Methodology: https://510kreport.com/methodology