Siddharth-II Impact Linear Accelerator
by Panacea Medical Technologies Pvt Ltd India EUDAMED510(k)
510(k) K222762
Product code IYE
Overview
The Siddharth-II Impact is a Linear Accelerator, Medical, designed for external beam radiotherapy. It delivers high-energy photon and electron beams to precisely target and treat malignant and benign tumours in oncology settings, adhering to radiologic precision standards.
This device is intended for use in hospital-based radiation oncology departments, supplied as a reusable medical system. It operates under regulatory oversight, including FDA 510(k) clearance and compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The system is classified as Class II under FDA regulations and is intended for MRI-unsafe environments. Multiple model and registration numbers (e.g., 3013410552, 3015232217) identify specific configurations, with no indication of single-use or sterility requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222762 | Date8 Jun 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- Siddharth-Ii;impact
- 510(k) Number
- FDA Product Code
- IYE
- Models / Variants
- FDA applicant
- Panacea Medical Technologies Pvt. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Panacea Medical Technologies Pvt Ltd
Questions
What types of tumors can the Siddharth-II Impact Linear Accelerator treat, and where is it typically used?
The Siddharth-II Impact is designed for external beam radiotherapy to target and treat both malignant (cancerous) and benign (non-cancerous) tumors. It is specifically intended for use in hospital-based radiation oncology departments, where precision is critical for delivering high-energy photon and electron beams to affected areas.
Is the Siddharth-II Impact Linear Accelerator single-use or reusable, and what does that mean for maintenance?
The Siddharth-II Impact is supplied as a reusable medical system, meaning it is built for repeated use in clinical settings. This design implies that it requires regular maintenance, calibration, and cleaning protocols to ensure consistent performance, safety, and compliance with regulatory standards over time.
How do I determine the correct model or configuration for my facility, given the multiple registration numbers listed?
The Siddharth-II Impact comes in various configurations, each identified by unique registration numbers (e.g., 3013410552, 3015232217). These numbers correspond to specific model variations, which may differ in technical specifications or capabilities. Your facility should consult Panacea Medical Technologies or a certified distributor to select the model best suited to your radiation oncology department’s requirements, ensuring compatibility with your existing infrastructure and treatment protocols.
Does the Siddharth-II Impact Linear Accelerator require any special storage conditions, and is it safe for use in all MRI environments?
The device is not designed for MRI-safe environments, meaning it should not be used in areas where MRI machines are operating. While the data does not specify exact storage conditions, reusable medical equipment like this typically requires a clean, controlled environment to prevent contamination and ensure longevity. Facilities should follow manufacturer guidelines for proper storage, including protection from physical damage and environmental factors.
What regulatory pathways has the Siddharth-II Impact Linear Accelerator followed, and how does that affect its use in different markets?
The Siddharth-II Impact has undergone FDA 510(k) clearance, indicating it is considered substantially equivalent to a predicate device in the U.S. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe, reflecting its classification as a Class II device under FDA regulations. These pathways ensure the device meets safety and performance standards in markets where these regulations apply, but facilities should verify local compliance requirements before use.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K222762
- EUDAMED