RADMAX Digital Imaging Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182537 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RADMAX Digital Imaging Software is a digital imaging software device intended for use in radiology. It provides diagnostic imaging capabilities with an intuitive interface to simplify workflows and minimize exam steps.
The software is supplied as a digital product and is designed for use with various X-ray systems, offering retrofit compatibility. It is intended for use in clinical settings and has received FDA 510(k) clearance under K182537 with product code LLZ.
Frequently asked questions
What is RADMAX Digital Imaging Software used for?
RADMAX Digital Imaging Software is intended for use in radiology to provide diagnostic imaging capabilities, featuring an intuitive interface designed to simplify workflows and minimize exam steps in clinical settings.
How is RADMAX Digital Imaging Software supplied and installed?
The software is supplied as a digital product and is designed for retrofit compatibility with various X-ray systems, allowing integration into existing clinical imaging setups without requiring hardware replacement.
Is RADMAX Digital Imaging Software reusable or single-use?
As a digital imaging software product, RADMAX is intended for repeated use in clinical environments; it is not a single-use device and does not require sterilization or disposal after each use.
What regulatory clearance does RADMAX Digital Imaging Software have?
RADMAX Digital Imaging Software has received FDA 510(k) clearance under submission K182537, with product code LLZ, and was determined to be substantially equivalent to a predicate device.
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: Software: RADMAX - DRGEM, Home - DRGEM, PDF MKCT2509-001_RADMAX_8P_R20(A4) - ti-ba.com, DRGEM DR Systems | TI-BA Enterprises
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182537 | Class II | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (1)
- FDA 510(k) K182537 24 fields · synced Sep 25, 2026