Merge Hemo
by Merge Healthcare Incorporated United States 510(k)
510(k) K152864 Product code DQK
Overview
The Merge Hemo is a Radiation-Emitting Product classified under X-Ray Assembler (Product Code: DQK), designed to display, measure, and record physiological data during invasive catheter-based diagnostic and interventional procedures. It integrates with imaging systems to provide real-time hemodynamic monitoring, supporting cardiovascular assessments in clinical settings.
This device is supplied as a reusable system and is intended for use in hospital or interventional radiology environments. It requires compliance with radiation safety standards and is regulated under FDA 510(k) clearance (K152864) for substantial equivalence in cardiovascular applications. No explicit sterility or single-use designation is noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152864 | Date7 Apr 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-2387-2021
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
-
- Terminated Z-0350-2018
Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
Specification
- 510(k) Number
- FDA Product Code
- DQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Merge Healthcare Incorporated
Questions
What types of clinical procedures is the Merge Hemo designed to support during real-time hemodynamic monitoring?
The Merge Hemo is specifically designed to support invasive catheter-based diagnostic and interventional procedures in cardiovascular assessments. It integrates with imaging systems to provide real-time hemodynamic monitoring, making it useful for procedures where precise measurement of physiological data is critical, such as coronary angiography or other interventional radiology cases.
Is the Merge Hemo intended for single-use or reusable applications in a clinical setting?
The Merge Hemo is supplied as a reusable system, meaning it is designed for repeated use in hospital or interventional radiology environments. This distinguishes it from single-use devices and aligns with its intended use in clinical settings where durability and repeated applications are necessary.
How is the Merge Hemo regulated, and what does its FDA clearance status indicate?
The Merge Hemo is regulated under the FDA 510(k) clearance process, specifically with clearance number K152864. Its classification as a Radiation-Emitting Product (X-Ray Assembler, Product Code DQK) and the substantial equivalence determination indicate that it has been deemed equivalent to a legally marketed predicate device for cardiovascular applications, ensuring compliance with safety and performance standards.
What kind of environments is the Merge Hemo intended for, and what safety considerations apply?
The Merge Hemo is intended for use in hospital or interventional radiology environments where invasive catheter-based procedures are performed. Due to its classification as a Radiation-Emitting Product, it must comply with radiation safety standards to ensure safe operation and minimize exposure risks during use.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K152864