CUBESCAN BIOCON-500 Diagnostic Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091518 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CUBESCAN BioCon-500 Diagnostic Ultrasound System is a portable ultrasound device classified as a diagnostic ultrasound system. It is designed to transmit ultrasound signals into the patient’s abdomen, receive echoed signals, and determine the bladder’s outline to calculate urine volume.
This system is intended for use in clinical settings to measure bladder volume via ultrasound imaging. Supplied as a reusable device, it requires appropriate sterilization procedures between uses. Authorized under FDA 510K clearance and MDD compliance, the BioCon-500 operates within standard medical imaging regulations without specific MRI safety restrictions noted.
Frequently asked questions
What clinical purpose does the CUBESCAN BioCon-500 Diagnostic Ultrasound System serve in a healthcare setting?
The CUBESCAN BioCon-500 is specifically designed to measure bladder volume via ultrasound imaging. It transmits ultrasound signals into the patient’s abdomen, analyzes the echoed signals, and calculates the bladder’s outline to determine urine volume. This is particularly useful in clinical settings for assessing urinary retention or post-void residual urine.
Is the CUBESCAN BioCon-500 a single-use or reusable device, and what sterilization steps are required?
The CUBESCAN BioCon-500 is a reusable device, meaning it must undergo proper sterilization procedures between uses to ensure patient safety and device integrity. Since it is not single-use, facilities must follow established protocols for cleaning and sterilizing the equipment before each subsequent use.
What regulatory pathways has the CUBESCAN BioCon-500 Diagnostic Ultrasound System followed, and how does this affect its use?
The device has been authorized under both FDA 510(k) clearance and MDD compliance, confirming it meets the necessary regulatory standards for diagnostic ultrasound systems in the U.S. and European markets. This ensures it adheres to safety and performance requirements for clinical use in measuring bladder volume.
Does the CUBESCAN BioCon-500 have any special safety considerations, such as MRI compatibility?
The device does not have specific MRI safety restrictions noted in its documentation, meaning it is not designed for use in MRI environments. However, standard electromagnetic interference precautions should still be followed when operating near other medical equipment to avoid potential interference.
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: MCUBE CUBESCAN BIOCON-500 USER MANUAL Pdf Download, MCUBE BIOCON-500 USER MANUAL Pdf Download | ManualsLib, Operation Principle - Mcube Technology, Mcube Technology Co., Ltd. BioCon-500 CUBEscan - RevMed
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K091518 | Class II | Active |
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Manufacturer
- Manufacturer
- Mcube Technology Co., Ltd.
Sources (2)
- FDA 510(k) K091518 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026