Mobius Medical Systems, LP

• IYE — Radiology3 devices

• Z-2100-2017 — Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.Class II·Terminated·2015-02-23

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K153014 — Mobius3DCode IYE·2016-04-29
• K141230 — DOSELAB PROCode IYE·2014-08-27
• K140660 — MOBIUS3DCode IYE·2014-06-24