New Ultrasound Replacement Transducer

over 150 models

Covex/Liner/Pased/Endocavity

The non-OEM ultrasound replacement transducer is a new business sector and has been formally recognized
by authorities. For instance, on 09-SEP-2008 the U.S. FDA formally revealed clear policy towards the
non-OEM ultrasound replacement transducers, which is quoted as follows:
“ Appendix B: Non-OEM Replacement Transducers
These transducers are generally those that are manufactured by a party other than the original
equipment manufacturer (OEM) and are intended to replac a transducer originally provided by the
system manufacturer. They can be either new transducers or original equipment transducers that
have been modified or remanufactured.
Like new OEM transducers, non-OEM, reprocessed, and remanufactured transducers are new
medical devices. As such, they are subject to the 510(k) premarket notification regulations(21 CRF 807.81). They need to have a cleared 510(k) prior to being marketed.
………………………………………………………………………………………………………………….………………………………………”
¾ Appendix B of ‘Guidance for Industry and FDA Staff - Information for Manufacturers
Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers’
Issued by U.S. FDA on 09-SEP-2008
In the European Union, the relevant requirements for the non-OEM ultrasound replacement transducer are
also indicated in EN 61157:1994 / IEC 61157:1992, which is quoted as follows:
“················ If a transducer assembly is provided by a company other than the original supplier of
the equipment then the new supplying company shall: ················ Ensure that the acous9c output
levels do not exceed those specified by the original manufacturer and shall specify this in a
statement, giving the original manufacturer’s type-tes9ng value. ·······················································”
¾ Clause 5 of EN 61157:1994 / IEC 61157:1992 ‘Requirements for the declaration of the
acoustic output of medical diagnostic ultrasonic equipment’
Pioneering in the sector of new ultrasound replacement transducer, so far Broadsound Corporation is the
sole company in the world who has the European Union CE0197 mark, U.S. FDA 510(k) Marketing Clearance,
and registration to other countries such as Russia and Brazil etc. on the new ultrasound replacement
transducer.
Broadsound new ultrasound replacement transducers are functionally comparable to the corresponding OEM
ones of leading brands in imaging; and, they are of brand-new design rather than the alternative used,
repaired, copied, or cloned products.
In the past, the expensive cost for new OEM transducers as well as the safety and maintenance issues for the
unreliable cloned, used or repaired transducers always made people indecisive. Now, the Broadsound new
ultrasound replacement transducers, which are officially approved by the European Union or U.S. FDA, may
be the end user’s best choice for the ultimate solution.
Targeting on aftermarket for the new ultrasound replacement transducer, we would serve the following two
groups of clients who need reliable, cost-effective, and high performance ultrasound transducers:
1. End users who are seeking excellent ultrasound transducers to replac damaged ones, and
2. Refurbished or pre-owned diagnostic ultrasound system dealers/providers who need
cost-effective and reliable ultrasound transducers.
The Broadsound Diagnostic Ultrasound Transducers List, which contains the relevant information of our
currently available models, is attached for your reference. Meanwhile, many new ultrasound replacement
transducers are under development and will become available soon.
Our preferred mode of business for the new ultrasound replacement transducer is B2B2C (Business to
Business to Customer); that is, Broadsound works with worldwide local professional partners/distributors to
serve regional end users.
Our offer is risk-free and satisfaction guaranteed; that is, we’ll refund the money paid for the transducer if
you or your clients are not satisfied with its performance.In contrast to the cloned, repaired and used transducers market, the market of new replacement transducers
is a new business sector; and, some end users might have following concerns:
1. Is the Broadsound new replacement transducer legitimate?
2. Will the Broadsound new replacement transducer harm patients?
3. Will the Broadsound new replacement transducer damage OEM ultrasound systems?
Firstly, the new ultrasound replacement transducer is surely legitimate as indicated in the guidance of U.S.
FDA and EN 61157:1994 / IEC 61157:1992 of European Union mentioned above.
Secondly, the above concerns of “Will the Broadsound new ultrasound replacement transducers harm
patients and/or damage OEM ultrasound systems?” regard issues of safety and compatibility, and the answer
to those concerns is an absolute “No”, which can be justified by the fact that Broadsound new ultrasound
replacement transducers comply with relevant safety regulations and are officially approved by authorities,
such as the CE0197 mark of European Union, 510(k) marketing clearance of U.S. FDA, and GMP certification of
Department of Health of Taiwan, R.O.C. etc.
Launching the marketing in 2007, we have now successfully sold the Broadsound new replacement
transducers and established good relationships with highly satisfied partners in more than 65 countries
globally. Some of our customers’ feedback is attached for your information.
With our risk-free offer, and guarantees in performance, image quality, and safety, the Broadsound new
ultrasound replacement transducers are the best choice to meet your transducer needs.