aScope 5 Cysto HD (Standard Deflection); aScope 5 Cysto HD (Reverse Deflection); aView 2 Advance
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Ambu A/S
Identity
- Trade Name
- Ambu® aView 2 Advanced EUDAMED
- Device Name
- aView 2 Advance EUDAMED
- Model / Reference
- aView 2 Advance EUDAMED405011000EUB1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707480156702 EUDAMED
- Basic UDI-DI
- 5707480301010110065 EUDAMED
- Direct Marketing DI
- 05707480145089 EUDAMED
- 510(k) Number
- K240848 FDA 510(k)
- FDA Product Code
- FAJ FDA 510(k)
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
No
Incorporates Medicinal Product
No
The aScope 5 Cysto HD is a flexible cysto-nephroscope designed for high-definition imaging in urological and nephrological procedures. It provides detailed visualization for diagnostic, therapeutic, and complex cystoscopy, including percutaneous nephrolithotomy (PCNL) and bladder cancer assessment, supported by an integrated HD camera sensor.
This device is supplied as a sterile, single-use system, paired with the portable aView 2 Advance display unit for real-time imaging. It is classified under FDA 510(k) clearance and MDR, with MR safety compliant for use in MRI environments. The system includes multiple model variants (e.g., Standard/Reverse Deflection) and is intended for use in clinical settings such as operating rooms or inpatient procedures.
Frequently asked questions
What types of procedures is the Ambu® aScope™ 5 Cysto HD designed to support, and how does its imaging quality benefit these procedures?
The Ambu® aScope™ 5 Cysto HD is specifically designed for high-definition imaging in urological and nephrological procedures, including diagnostic cystoscopy, therapeutic interventions, and complex surgeries like percutaneous nephrolithotomy (PCNL) and bladder cancer assessment. Its integrated HD camera sensor provides detailed visualization, which enhances precision during these procedures by offering clearer and more accurate views of internal structures.
Is the Ambu® aScope™ 5 Cysto HD system reusable, or is it intended for single-use only? How does this affect its use in clinical settings?
The Ambu® aScope™ 5 Cysto HD is supplied as a sterile, single-use system. This design reduces the risk of cross-contamination between patients and eliminates the need for reprocessing, streamlining workflows in clinical settings such as operating rooms or inpatient procedures. Single-use also ensures consistent performance and reliability for each procedure.
What display unit is required to use the Ambu® aScope™ 5 Cysto HD, and how does it integrate with the scope?
The Ambu® aScope™ 5 Cysto HD is paired with the portable aView™ 2 Advance display unit for real-time imaging. This integration allows clinicians to view high-definition visuals directly from the scope during procedures, ensuring seamless operation and improved diagnostic or therapeutic accuracy.
Are there different models of the Ambu® aScope™ 5 Cysto HD, and what variations should clinicians consider when selecting one?
Yes, the Ambu® aScope™ 5 Cysto HD comes in two deflection variants: Standard Deflection and Reverse Deflection. Clinicians should select the model based on their specific procedural needs—Standard Deflection may be preferred for general cystoscopy, while Reverse Deflection could offer advantages in complex or confined anatomical spaces, such as certain nephrological interventions.
Can the Ambu® aScope™ 5 Cysto HD be used in an MRI environment, and what safety considerations should be noted?
Yes, the Ambu® aScope™ 5 Cysto HD is MR safety compliant, meaning it can be used in MRI environments without interfering with imaging or posing risks to patients. However, clinicians should follow standard MRI safety protocols, including ensuring proper grounding and avoiding metallic contamination of the MRI environment, to maintain both device functionality and patient safety.
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: Ambu aScope 5 Cysto HD | Cysto-nephroscope | Ambu, Ambu aScope 5 Cysto HD | Cysto-nephroscope | Ambu, Ambu® aScopeTM 5 Cysto HD Flexible Cysto-Nephroscope, Ambu cystoscopes | Single-use | Ambu
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 | K240848 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (2)
- FDA 510(k) K240848 24 fields · synced Sep 18, 2026
- EUDAMED 56a7e353-bbc4-413d-b0b3-22f6ffdb2e9c 61 fields · synced Jul 9, 2026