MOSAIQ Oncology Information System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141572 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MOSAIQ Oncology Information System is a medical device classified as an Accelerator, Linear, Medical under FDA device classification. It is a software system designed for oncology information management, supporting clinical workflows in radiation and medical oncology settings.
The system is supplied as a reusable software platform, authorized via FDA 510(k) clearance (K141572) and intended for use in healthcare facilities. It requires appropriate computational infrastructure and is not sterile, single-use, or implantable. No MRI safety information, storage conditions, or size specifications are provided in the data.
Frequently asked questions
What is the MOSAIQ Oncology Information System used for?
The MOSAIQ Oncology Information System is a software system designed for oncology information management, supporting clinical workflows in radiation and medical oncology settings. It is classified as an Accelerator, Linear, Medical device under FDA regulations and is intended for use in healthcare facilities to manage patient data, treatment planning, and care coordination.
Is the MOSAIQ Oncology Information System sterile, single-use, or implantable?
The MOSAIQ Oncology Information System is supplied as a reusable software platform and is not sterile, single-use, or implantable. It requires appropriate computational infrastructure to operate and is designed for repeated use within healthcare facilities after installation and configuration.
How is the MOSAIQ Oncology Information System authorized for use?
The MOSAIQ Oncology Information System is authorized via FDA 510(k) clearance under submission K141572, which determined it to be substantially equivalent to a legally marketed predicate device. This clearance permits its use in healthcare facilities for oncology information management as described in the labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MOSAIQ OIS - Siemens Healthineers, PDF MOSAIQ User's Guide, Medical Oncology | Oncology Informatics | Software | Elekta, The IMPAC acquisition | Our Story | Cancer Care | Elekta
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141572 | Class II | Active |
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Manufacturer
- Manufacturer
- Impac Medical Systems, Inc.
Sources (1)
- FDA 510(k) K141572 24 fields · synced Sep 25, 2026