# K222762: Siddharth-II;Impact

- Pathway: 510(k) (Traditional)
- Applicant: Panacea Medical Technologies Pvt., Ltd.
- Decided: Jun 8, 2023 after 268 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: 14 generations back to K926449 (1995). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210894: Siddharth-II; Impact, Panacea Medical Technologies Pvt., Ltd. (2021) Summary page 4.

## 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. 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.

Source page: https://510kreport.com/device/K222762
Methodology: https://510kreport.com/methodology