GammaPod - Model A— 510(k) K172706

Name: FDA 510(k) clearance K172706
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Substantially Equivalent

Xcision Medical Systems, LLC

FDA 510(k) clearance K172706 for GammaPod - Model A, Substantially Equivalent on 2017-12-22. Applicant: Xcision Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Xcision Medical Systems, LLC
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2017-09-07
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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K180571 — GammaPod2018-04-04

Recalls naming K172706

K-number listed on FDA's recall record

Z-0750-2024 — GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.Class II·Ongoing·Xcision Medical Systems, LLC·20231130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172706.

Data sourced from openFDA. This site is unofficial and independent of the FDA.