Identity
- Trade Name
- RAPID Software EUDAMED
- Device Name
- Rapid Software EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RapidSoftwareY7 EUDAMED
- Basic UDI-DI
- B-RapidSoftwareY7 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Rapid Software is a medical device software classified under nomenclature code Z11069092, designed for measuring physiological or analytical data. It functions as an active diagnostic tool, enabling quantitative analysis of medical information for clinical decision-making.
This software is supplied by iSchemaView, Inc. and is non-sterile, non-reusable, and non-implantable. It carries FDA 510K and MDD authorizations, with a Basic UDI of B-RapidSoftwareY7. The device is intended for single-use applications in regulated clinical environments, adhering to Class IIa risk classification standards.
Frequently asked questions
What is the primary purpose of the RAPID Software in a clinical setting?
The RAPID Software is designed as an active diagnostic tool to measure and analyze physiological or analytical medical data. It supports quantitative analysis of clinical information, aiding healthcare providers in making informed decisions during patient care.
Is the RAPID Software intended for repeated use in a single patient or a single-use application?
The RAPID Software is explicitly designed for single-use applications in regulated clinical environments. Since it is non-reusable, each installation or deployment is intended for one specific use case or session.
How is the RAPID Software classified under regulatory standards, and what does this mean for its use?
The RAPID Software is classified as a Class IIa medical device under the nomenclature code Z11069092. This classification indicates it carries a moderate risk level, requiring compliance with specific regulatory controls to ensure safety and performance in clinical settings.
What does the Basic UDI (Unique Device Identifier) for the RAPID Software represent, and how can it be used?
The Basic UDI for the RAPID Software is B-RapidSoftwareY7, which serves as a standardized identifier to trace and track the device throughout its lifecycle. It helps in inventory management, regulatory compliance, and ensuring the correct version of the software is deployed in clinical environments.
Does the RAPID Software require any special handling or storage conditions, and is it sterile?
The RAPID Software is non-sterile and does not require specialized sterilization or storage conditions beyond standard IT and software deployment protocols. Since it is non-reusable and non-implantable, its primary consideration is proper installation and maintenance in a controlled clinical environment.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121447 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K172477 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213165 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182130 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K233582 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-RapidSoftwareY7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
- EUDAMED SRN
- US-MF-000040716
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fc57bf3b-52f9-42b7-90de-7c7833228c7f 61 fields · synced Sep 18, 2026
- FDA 510(k) K121447 1 fields · synced May 18, 2026