FDA 510(k)

GammaPod

K-Number: K180571 · 2018-04-04

Decision Date2018-04-04

Product CodeIWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GammaPod is the device name listed in this FDA 510(k) record. The listed applicant is Xcision Medical Systems, LLC. It received FDA 510(k) clearance on 2018-04-04 under 510(k) 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. The listed applicant is Xcision Medical Systems, LLC. The 510(k) number is K180571.

When did GammaPod receive FDA 510(k) clearance?

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

Who is the listed applicant for GammaPod?

The FDA 510(k) record lists Xcision Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GammaPod?

The FDA product code for GammaPod is IWB.

Other records listing Xcision Medical Systems, LLC 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.

K172706GammaPod - Model A

Related Devices (Code: IWB)

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions AB K232854Leksell GammaPlan (LGP)Elekta Solutions AB K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions AB K203250TaiChiCOur United Corporation K203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, 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.