Regulation Number: 21 CFR 884.2660, Product Code: LXE, MAA. Regulation Number 892.157021, Product Code ITX22, IYN22 and IYO23
Compliance Consultants has accomplished many Ultrasonic Imaging
systems that offer an array of diagnostic possibilities. An ultrasonic
imaging system consisting of an integral transducer & catheter that connect
to an ultrasonic transmitter/receiver. This system provides a diagnostic
session to image, display, store and publish patient diagnostic images. This
is a prescription device used for orthopedic or pathological imaging. The
catheter is inserted into the patient at the region of interest via a surgical
procedure. The diagnostic session allows the physician to image joints,
ligaments or tendons by less invasive means than traditional diagnostic
methods.
"Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers http://www.fda.gov/cdrh/ode/ulstran.pdf" for a Class II device. We will submit a certified measurement methodology in the 510(k) application. We will provide a Declaration of Conformity to a standard or provide data to establish the device is thermally, electronically and mechanically safe. The Model 601 conforms to applicable portions of guidance document "Draft Guidance for Arthroscope and Accessory 510(k)S, http://www.fda.gov/cdrh/ode/odegr909.html" and "Draft Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements, http://www.fda.gov/cdrh/ode/832.html".
"Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers http://www.fda.gov/cdrh/ode/ulstran.pdf" for a Class II device. We will submit a certified measurement methodology in the 510(k) application. We will provide a Declaration of Conformity to a standard or provide data to establish the device is thermally, electronically and mechanically safe. The Model 601 conforms to applicable portions of guidance document "Draft Guidance for Arthroscope and Accessory 510(k)S, http://www.fda.gov/cdrh/ode/odegr909.html" and "Draft Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements, http://www.fda.gov/cdrh/ode/832.html".
