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FDA 510(k)

GammaPod

K-Number: K180571 · 2018-04-04

ApplicantXcision Medical Systems, LLC
Decision Date2018-04-04
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GammaPod is a medical device manufactured by Xcision Medical Systems, LLC. It received FDA 510(k) clearance on 2018-04-04 under approval number K180571. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GammaPod?

GammaPod is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Xcision Medical Systems, LLC. The 510(k) number is K180571.

When was GammaPod approved by the FDA?

GammaPod received FDA 510(k) clearance on 2018-04-04, under approval number K180571.

What company makes GammaPod?

GammaPod is manufactured by Xcision Medical Systems, LLC.

What is the FDA product code for GammaPod?

The FDA product code for GammaPod is IWB.

Other Devices by Xcision Medical Systems, LLC

K172706GammaPod - Model A

Related Devices (Code: IWB)

K160440Leksell Gamma Knife IconElekta Instrument AB K172706GammaPod - Model AXcision Medical Systems, LLC K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB K173791Leksell GammaPlanElekta Instrument AB K190844Akesis GalaxyAkesis, Inc. K200050Akesis Galaxy RTxAkesis, Inc.

Official Source

View on FDA Database →

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

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