GammaPod— 510(k) K180571

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

2018-03-05

Decision date

2018-04-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Columbia, MD, US

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• K172706 — GammaPod - Model A2017-12-22

• 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
• Z-2081-2019 — GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device 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·Terminated·Xcision Medical Systems, LLC·20190703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180571.