FOR IMMEDIATE RELEASE:
MERIDIAN MEDICAL RECEIVES FDA CLEARANCE FOR MONARCH UHD
Meridian Medical Systems is pleased to announce that it has received FDA clearance to market their new Meridian Monarch Ultra High Definition (UHD) Universal Digital Imager (UDI) with Wireless Detector with Automatic Exposure Detection (AED). According to Meridian President Larry Cornell, the extensive approval process included the Monarch UDI 2 and the Monarch UDI 2 with wireless/AED. The digital system has been cleared to be used for both pediatric and adult radiographic imaging.
The FDA’s decision was announced February 2, 2015.
Meridian’s Monarch UDI 2 with UHD sets the standard for clarity and detailed images, reliable image acquisition, mobility, and ruggedness. The software is specified to operate as a certified component when used with the Meridian Operators Console to control the x-ray generator and other acquisition and display parameters. The Monarch UHD is used with a 20″ (4K) acquisition console that features 3840 x 2560 display resolution (9.8mp), four times that of typical acquisition stations, creating images at resolution typically seen only on high-resolution diagnostic workstations. Its advanced software displays those images twice as fast as most other workstations. It is primarily noted for its advanced workflow features, mobility, image quality, and reliability.
- Imaging panels feature “Quad Cell Technology,” which includes direct Csl vapor deposit to increase both contrast and resolution, a reflective layer coating that increases sensitivity by 1.8 times, and moisture-proof sealing for reliability and long life, all at the lowest dose possible.
- Meridian’s “Surefire” automatic exposure detection (AED) senses the x-ray and automatically acquires the image without requiring a wired connection to the generator, enabling the Monarch UHD to be used on any new or existing x-ray capable system.
- Simply use it with any analog mobile x-ray system or Radiographic/RF room and that system becomes digital immediately anywhere, anytime there is an x-ray source.
- The waterproof design of the 20″ mobile tablet “operators’ console” enables it to withstand the near-constant wipe downs required to maintain 100% sanitation compliance.
The Meridian Monarch UHD is one of a number of FDA 510k-cleared products in Meridian’s portfolio. According to Cornell, each submission improved system functionality and performance. This system has been designed to meet or exceed the recommendations of the ACR, the AHRA, the Alliance for Radiation Safety in Pediatric Imaging (ARSPI), and Alliance for Radiology Safety in Adult Imaging (ARSAI).
According to Cornell, the FDA granted clearance based on a full range of high-performance qualities including “system specifications, quality system management, dose parameters for pediatrics, and non-clinical test data and performance for solid-state detectors.”
Meridian supports and abides by “Image Gently” and “Image Wisely” recommendations of both the ARSPI and ARSAI.
What does FDA clearance mean for Meridian Medical Systems users?
In today’s increasing service-driven economy a medical organization’s greatest asset—and cost—is in its workforce and their time. Optimizing this time is at the heart of a medical imaging center’s strategy. With an ever-increasing number of x-ray exams that require mobility, the Meridian Monarch Digital Acquisition System is used to acquire images from any location, on any radiographic unit (analog or digital), and instantly send the images to the radiology review station or PACS. The greatest value of the Meridian Monarch is the gift of time—both for the technologist productivity and the commitment to the best patient care available.
Meridian Medical Systems provides digital radiographic solutions to the healthcare industry. The company has developed proprietary universal digital applications designed to supplement or convert installed analog x-ray systems to state-of-the-art digital flat-panel technology. The company also offers a complete digital radiographic and fluoroscopic product line. The company is located in Aurora, Ohio. For more information about Meridian Medical Systems, visit their website at www.meridianmed.net, call 330-995-0371, or email firstname.lastname@example.org.