IMSure Brachy QA Software, Model 91331
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- IMSure 3D EUDAMEDIMSure EUDAMEDStandard Imaging IMSure 3D QA Software FDA UDIStandard Imaging IMSure 3D FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- IMSure EUDAMEDStandard Imaging IMSure 3D software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy. FDA UDIStandard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy. FDA UDI
- Model / Reference
- 91355 EUDAMEDFDA UDI91365 EUDAMEDFDA UDI
- Description
- Standard Imaging IMSure 3D software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy. FDA UDIStandard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy. FDA UDI
Identifiers
- Catalog Number
- 91355 FDA UDI91365 FDA UDI
- Primary DI / UDI-DI
- 00850019946604 EUDAMEDFDA UDI00850019946543 EUDAMEDFDA UDI
- Basic UDI-DI
- 08665620002IMSURE8S EUDAMED
- FDA Product Code
- IYE FDA 510(k)FDA UDI
- EMDN Code
- Z11010182 LINEAR ACCELERATORS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The IMSure Brachy QA Software, Model 91331, is a quality assurance (QA) software tool designed specifically for brachytherapy applications. It performs second checks on high-dose rate (HDR), low-dose rate (LDR), and permanent implant plans, ensuring accuracy and compliance with treatment protocols.
This software is intended for use in radiology settings to validate brachytherapy plans through visual 3D verification of calculation and reference points. Supplied as a standalone software solution, it requires no additional hardware and operates on standard computing platforms. Authorized under FDA 510K and MDR, the device adheres to regulatory standards for medical software in radiology, ensuring reliability and traceability in clinical workflows.
Frequently asked questions
What types of brachytherapy plans does the IMSure Brachy QA Software validate, and how does it ensure accuracy in treatment protocols?
The IMSure Brachy QA Software, Model 91331, is designed to perform second checks on high-dose rate (HDR), low-dose rate (LDR), and permanent implant brachytherapy plans. It ensures accuracy by providing visual 3D verification of calculation and reference points, helping clinicians confirm compliance with treatment protocols before administration. This reduces human error and supports reliable workflows in radiology settings.
Does the IMSure Brachy QA Software require any additional hardware to operate, and what computing platforms does it support?
No, the IMSure Brachy QA Software is a standalone solution that does not require any specialized hardware beyond standard computing platforms. It is intended to integrate seamlessly into existing radiology workflows, ensuring accessibility without additional infrastructure.
How is the regulatory compliance of this software demonstrated, and which regulatory bodies have authorized its use?
The IMSure Brachy QA Software has been authorized under FDA 510K clearance and MDR (Medical Device Regulation) compliance, confirming its adherence to regulatory standards for medical software in radiology. These authorizations validate its reliability and traceability in clinical brachytherapy quality assurance workflows.
Is the software intended for single-use or repeated use in clinical settings, and how should it be maintained?
The IMSure Brachy QA Software is a software-only solution, meaning it is designed for repeated use in clinical settings. Since it lacks physical components, maintenance primarily involves ensuring the host computing system meets technical requirements (e.g., OS compatibility, hardware specifications) and performing routine software updates as provided by the manufacturer.
What is the primary purpose of the IMSure Brachy QA Software in a radiology department’s brachytherapy workflow?
The primary purpose of the IMSure Brachy QA Software is to serve as a second-check verification tool for brachytherapy plans. It helps radiology departments validate HDR, LDR, and permanent implant treatments by cross-referencing calculations and reference points in a 3D visualization format, reducing the risk of errors before patient treatment begins.
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: IMSure™ QA Software, (Brachytherapy Only) | Standard Imaging, IMSure QA™ Software | Standard Imaging, Standard Imaging Imsure Brachy Qa Software, Model 91331 (K082773) — Fda ..., Standard Imaging Imsure Brachy Qa Software, Model 91331
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K082773 | Class II | Active |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (5)
- FDA 510(k) K082773 24 fields · synced Sep 20, 2026
- FDA UDI 75800e6d-d9cd-4348-a0d3-adcc35f8914a 35 fields · synced May 24, 2026
- FDA UDI 654ffbfb-c38b-49a5-bf99-2e504979c18d 34 fields · synced May 30, 2026
- EUDAMED f503f03b-afdb-439c-9cbe-fdbdd468ff87 61 fields · synced Jul 13, 2026
- EUDAMED c4957c36-c090-411b-9f05-d03abd3837c5 61 fields · synced Aug 3, 2026