(76 days)
Diagnostic imaging or fluid flow analysis of the human body as follows:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number(s):
K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .
K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System .
K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System .
The Cypress Ultrasound System has been designed to conform to the following product safety standards:
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for . Diagnostic Ultrasound
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
93/42/EEC Medical Device Directive .
Safety and EMC Requirements for Medical Equipment ●
EN 60601-1 .
EN 60601-1-1, Safety Requirements for Medical Equipment .
EN 60601-1-2 .
EN 60601-1-2-37 ●
ISO 10993 Biocompatibility .
The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of any study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone performance, ground truth types, or training set details. This document is a 510(k) summary for an ultrasound system, primarily focusing on its regulatory classification, predicate devices, device description, and intended uses, along with various transducer-specific indications. It states that the device is "substantially equivalent" to previously cleared predicate devices but does not provide details of any new study conducted to demonstrate this.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.