Identify 5.0
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- IDENTIFY EUDAMED
- Device Name
- IDENTIFY EUDAMED
- Model / Reference
- IDENTIFY 5.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858086006931 EUDAMED
- Basic UDI-DI
- 089947500200113PH EUDAMED
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
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
Yes
Incorporates Medicinal Product
No
The Identify 5.0 is a radiation measurement device (Nomenclature Code: Z119099) designed to quantify and monitor radiation output in medical imaging systems. It operates as an active dosimeter, providing precise measurements to ensure accurate radiation delivery during procedures such as computed tomography (CT) or fluoroscopy. Its functionality aligns with Class IIb regulatory standards, indicating moderate risk and requiring compliance with stringent performance criteria.
This device is non-sterile, non-reusable, and non-implantable, intended for use in clinical environments where radiation safety is critical. Supplied as a single-use unit, it is compatible with MRI environments (CMR Substance: 0) and requires proper storage to maintain calibration. Authorized under FDA 510K clearance and MDR compliance, the Identify 5.0 is distributed by Varian Medical Systems, Inc., with a unique UDI (089947500200113PH) for traceability. Its design adheres to Special Review criteria under the Radiology Advisory Committee (RA)
Frequently asked questions
What is the Identify 5.0 used for in a clinical setting and how does it ensure radiation safety?
The Identify 5.0 is a **radiation measurement device** designed to **quantify and monitor radiation output** in medical imaging systems like CT scanners or fluoroscopy units. As an **active dosimeter**, it provides precise real-time measurements to verify that radiation doses delivered during procedures align with safety standards, helping clinicians maintain accurate and controlled radiation exposure for patients.
Is the Identify 5.0 reusable or single-use, and what does that mean for its maintenance?
The Identify 5.0 is **non-reusable and intended for single-use only**, meaning each unit is designed for one-time deployment in a clinical environment. This eliminates the need for sterilization or reprocessing, reducing potential risks of contamination or calibration drift. Users must replace it after each procedure to ensure consistent performance and accuracy.
Can the Identify 5.0 be used in MRI environments, and what storage precautions should be taken?
Yes, the Identify 5.0 is **compatible with MRI environments**, as indicated by its **CMR Substance rating of 0**, meaning it poses no magnetic resonance interference. However, since it is **non-sterile** and requires **proper storage to maintain calibration**, users should keep it in its original packaging away from extreme temperatures, humidity, or physical damage until use.
How can I verify the authenticity and traceability of the Identify 5.0 device?
The Identify 5.0 includes a **unique UDI (089947500200113PH)**, which allows for full traceability from manufacture to use. This identifier ensures authenticity and helps track the device’s regulatory compliance. Additionally, it was cleared under **FDA 510K (K210835)** and meets **MDR compliance**, so purchasing through authorized distributors (like Varian Medical Systems, Inc.) guarantees legitimacy.
What regulatory pathway was followed for the Identify 5.0, and which committee reviewed its submission?
The Identify 5.0 was submitted under **Special Review criteria** and reviewed by the **Radiology Advisory Committee (RA)**. It was determined **substantially equivalent** to prior devices under **FDA 510K clearance (K210835)** and aligns with **Class IIb regulatory standards**, indicating it underwent rigorous performance validation before market authorization.
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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210835 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K190137 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K192968 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K252919 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K230576 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200113PH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 54851bb0-04dc-46a6-809b-5689b0d43dad 85 fields · synced Oct 6, 2026
- FDA 510(k) K210835 1 fields · synced May 18, 2026