Cleared Traditional

SIDDHARTH-II (K210894) - FDA 510(k) Clearance

Also marketed or referenced as:
IMPACT

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210894 · Panacea Medical Technologies Pvt. , Ltd. · Radiology device
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Sep 2021
Decision
187d
Days
Class 2
Risk

K210894 is an FDA 510(k) clearance for the SIDDHARTH-II. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Panacea Medical Technologies Pvt. , Ltd. (Malur, Kolar District, IN). The FDA issued a Cleared decision on September 28, 2021 after a review of 187 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Panacea Medical Technologies Pvt. , Ltd. devices

Submission Details

510(k) Number K210894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2021
Decision Date September 28, 2021
Days to Decision 187 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 107d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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