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FDA 510(k)

SIDDHARTH-II;IMPACT

K-Number: K222762 · 2023-06-08

ApplicantPanacea Medical Technologies Pvt. , Ltd.
Decision Date2023-06-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIDDHARTH-II;IMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Panacea Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K222762. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIDDHARTH-II;IMPACT?

SIDDHARTH-II;IMPACT is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Panacea Medical Technologies Pvt. , Ltd.. The 510(k) number is K222762.

When did SIDDHARTH-II;IMPACT receive FDA 510(k) clearance?

SIDDHARTH-II;IMPACT received FDA 510(k) clearance on 2023-06-08, under 510(k) number K222762.

Who is the listed applicant for SIDDHARTH-II;IMPACT?

The FDA 510(k) record lists Panacea Medical Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIDDHARTH-II;IMPACT?

The FDA product code for SIDDHARTH-II;IMPACT is IYE.

Other records listing Panacea Medical Technologies Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210894SIDDHARTH-II; IMPACT

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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