Other-Sonic™ Transmission Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.

Device Description

Other-Sonic™ Transmission Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles.

AI/ML Overview

The device under review is "Other-Sonic™ Transmission Gel," which is a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. The device is compared to a predicate device, "Sonishield™ 100 Antimicrobial Ultrasound Gel," and an additional reference device, "Ecogel 100 Ultrasound Gel."

Here's the breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance metric but rather presents a comparison of technological and non-clinical characteristics between the subject device and the predicate/reference devices to demonstrate substantial equivalence. The "performance" column below reflects the characteristics of the "Other-Sonic™ Transmission Gel" and the "Acceptance Criteria" column indicates that its performance should be substantially equivalent or similar to the predicate/reference devices for these characteristics.

Acceptance Criteria (Compared to Predicate/Reference)	Reported Device Performance (Other-Sonic™ Transmission Gel)
Acoustic Performance:
Sound velocity similar to predicate	1601 ms-1 at 22.5°C (Predicate: 1497 ms-1 at 30°C)
Density similar to predicate	1033 kg/ m3 at 22.5°C (Predicate: 1023 kg/ m3 at 30°C)
Acoustic impedance similar to predicate	1.65 MRayls at 22.5°C (Predicate: 1.53 MRayls at 30°C)
Attenuation coefficient similar to predicate	0.19 + 0.0000105 $f^{2.974}$ (Predicate: 0.04 ± 0.0042 $f$)
Antimicrobial Effectiveness:
Pass USP <51> (Category 2) log reductions	Passed with log reductions > 5 for bacteria, yeasts and molds decreased
Biocompatibility:
Non-sensitizing	Non-sensitizing
Non-irritating	Non-irritating
In Vitro Cytotoxicity:
Not considered cytotoxic (per ISO 10993-5:2009)	Not considered cytotoxic
Physical/Chemical Properties:
Salt free	Salt free
Alcohol free	Alcohol free
Formaldehyde free	Formaldehyde free
pH range (comparable to predicate)	6.80 ± 0.25
Density (g/mL) (comparable to predicate)	1.033
Viscosity (comparable to predicate)	966,000 ± 483,000 CPS
Boiling Point (comparable to predicate)	> 200° C
Water soluble high MW polymers	Water soluble high MW polymers
No irritation	No irritation
Other:
External Use	External
Pediatric and adult Target Population	Pediatric and adult
Multiple Uses	Multiple uses
Hospital Environment of Use	Hospital

2. Sample Size Used for the Test Set and Data Provenance:

Acoustic Testing: The document does not specify a separate "test set" sample size for acoustic testing. The acoustic properties are reported as values for "Other-Sonic™ Transmission Gel" and "Sonishield™ 100 Antimicrobial Ultrasound Gel." It implicitly compares the characteristics of the gel rather than a study on a specific number of instances.
Antimicrobial Effectiveness Testing: The sample size is not explicitly stated as a number of distinct gel samples. However, the test was performed according to USP <51> (Category 2) using standard microbial challenges: Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, and Candida albicans ATCC 10231. These represent specific strains used in lab testing.
Biocompatibility (Skin Irritation and Sensitization): The document states "Animal tests" were conducted, referring to "Skin Irritation and Skin Sensitization." The number of animals or specific experimental setup (e.g., number of patches, individual subjects) is not provided.
In Vitro Cytotoxicity: The test was conducted according to ISO 10993-5:2009. The sample size refers to the cell cultures used in the in vitro test, but specific numbers are not given.
Data Provenance: The document does not specify the country of origin for the non-clinical test data. These tests are typically conducted in laboratory settings (i.e., in vitro or in vivo animal studies) rather than using retrospective or prospective human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable. The evaluations conducted for this device (acoustic properties, antimicrobial effectiveness, biocompatibility, cytotoxicity) are non-clinical laboratory tests. They do not involve expert interpretation of images or clinical data to establish a "ground truth" in the way a diagnostic algorithm might. The "ground truth" for these tests comes from established scientific methodologies and standards (e.g., USP <51>, ISO 10993).

4. Adjudication Method for the Test Set:

This section is not applicable as the studies were non-clinical laboratory tests that do not involve human adjudication of results in the context of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No MRMC comparative effectiveness study was done. This device is an ultrasound transmission gel, not an AI-powered diagnostic tool requiring human reader assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone (algorithm-only) performance was done because this is a physical medical device (ultrasound transmission gel), not an algorithm or AI software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance claims comes from:

Acoustic Properties: Direct physical measurements of the gel's sound velocity, density, acoustic impedance, and attenuation coefficient.
Antimicrobial Effectiveness: Quantitative microbial count reductions as measured by standard microbiological assays (USP <51>).
Biocompatibility: Results from standardized animal (in vivo) irritation and sensitization tests (ISO 10993-10).
In Vitro Cytotoxicity: Results from standardized cell culture tests (ISO 10993-5:2009) to assess cell viability.

8. The Sample Size for the Training Set:

This section is not applicable. This device is a physical product (ultrasound transmission gel) and does not involve AI or machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Pharmaceutical Innovations, Inc. Shirley J. Bergman Vice President 897 Frelinghuvsen Ave. NEWARK, NJ 07114

January 8, 2018

Re: K163023

Trade/Device Name: Other-Sonic TM Transmission Gel Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: MUI Dated: December 8, 2017 Received: December 13, 2017

Dear Ms. Bergman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Robert A. Ochs. Ph.I Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K163023

Device Name

Other-Sonic™ Transmission Gel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo featuring a stylized letter 'P' enclosed within a rounded square. The 'P' is formed by two vertical lines connected by a curved top, all outlined in blue. The square border is also blue, providing a clean and simple design. The logo appears to be for a company or organization whose name starts with the letter 'P'.

Image /page/3/Picture/3 description: The image shows a logo with a flag on the left side and text on the right side. The flag has the letter "E" and a star on it. The text on the right side reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax:

510(k) Summary

Other-Sonic™ Transmission Gel

I. SUBMITTER

Pharmaceutical Innovations, Inc. 897 Frelinghuysen Ave. Newark, New Jersey 07114-2195 Phone: (973) 242-2900 Fax: (973) 242 0578 Contact Person: Ms. Shirley J Bergman Vice President.

Date Prepared: Friday, October 21, 2016

II. DEVICE

Name of Device: Other-Sonic™ Transmission Gel

Classification Name: Diagnostic ultrasonic transducer (accessory) (21 CFR 892.1570)

Regulatory Class: II

Product Code: MUI

III. PREDIČATE DEVIČE

Device Name: Sonishield™ 100 Antimicrobial Ultrasound Gel

Classification Name: Diagnostic ultrasonic transducer. (21 CFR 892.1570)

Regulatory Class: II

Product Code: MUI

510K Number: K151070

Additional Reference Device: Ecogel 100 Ultrasound Gel

Classification Name: Diagnostic ultrasonic transducer. (21 CFR 892.1570)

Regulatory Class: II

Product Code: ITX

510K Number: K961757

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Image /page/4/Figure/1 description: The image shows a logo with a stylized letter 'P' inside a rounded square frame. The 'P' is formed by two parallel lines with curved tops, creating a sense of depth and dimension. The logo is colored in a light blue hue, which gives it a clean and modern appearance. The overall design is simple yet distinctive, making it easily recognizable.

Image /page/4/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter 'E' and a star on it. The text reads 'PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING'. The logo appears to be an award or recognition for excellence in exporting.

venue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242

IV. DEVICE DESCRIPTION

It is packaged in 5L Cubitainers and 250 mL bottles.

Major characteristics include:

Non-sensitizing, non-irritating ●
Water soluble, non-staining, and easily cleanable
. Does not contain oil or fatty matter
Does not damage the probe
pH level is 6.80 ± 0.25 @ 25°C
Resists thinning and decomposition when exposed to perspiration and body heat
Sheer thinning gel is easy to apply, but doesn't run or drip
High viscosity allows for thick application, adapting to contours and hair to minimize interference

V. INDICATIONS FOR USE

The Indications for Use statement is as follows:

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Image /page/5/Figure/1 description: The image shows a logo with a stylized letter 'H' inside an oval shape, all enclosed within a square border. The 'H' is formed by two parallel lines with curved tops, giving it a unique and modern look. The oval shape encircles the top part of the 'H', adding depth to the design. The entire logo is rendered in a light blue color, providing a clean and professional appearance.

Image /page/5/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter E on it and a star above it. The text on the right says "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

897 Frelinghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Other-Sonic™ Transmission Gel has substantially the same technological characteristics as the predicate device, as well as the reference device. The three are compared below:

Subject	Other-Sonic™ TransmissionGel	Sonishield™ 100Antimicrobial UltrasoundGel	Ecogel 100Ultrasound Gel
Intended Use	External	External	External
Ingredients	Salt free	Salt free	Salt free
	Blue coloring	Dye free	Green coloring*
	Alcohol free	Alcohol free	Alcohol free
	Formaldehyde free	Formaldehyde free	Formaldehyde free
	Contains fragrance	Perfume free	Perfume free
PhysicalProperties	Twist cap for accuratedispensing(Snap-top on Cubitainers)	Twist cap for accuratedispensing	Twist cap foraccuratedispensing
	Twist-off top for quickrefilling.	Flip-top can for quickrefilling	Flip-top can forquick refilling
ChemicalProperties	High clarity	Very high clarity	Good clarity
	Bacteriostatic, nonsensitizing	Hypoallergenic,bacteriostatic,nonsensitizing	Hypoallergenic,bacteriostatic,nonsensitizing
	pH 6.80 ± 0.25	pH 4.5 - 6.5	pH 6.5 ± 0.75
	Density (g/mL) = 1.033	Density (g/mL) = 1.009	Density (g/mL) =0.99
	Stabilized, high viscosityformulation resists meltingand decomposition frombody heat and perspiration,providing lastingconductivity with zero orminimal reapplication.	Very clear screen imagewith high viscosity andvacuum process. No rapidmelting from highviscosity gel.	It has low viscosity.It meltsimmediately fromlow viscosity
	Viscosity 966,000 ± 483,000CPS	Viscosity 80,000 - 120,000CPS	Viscosity 35,000 -40,000 CPS
	Boiling Point > 200° C	Boiling point > 200° C	Boiling point 100°C
	Water soluble high MWpolymers	Water soluble high MWpolymer	Water soluble highMW polymer
	No irritation	No irritation	No irritation
Process	Normal process	It has a rapidmanufacturing process	Normal process
	Standard bottle (Cubitainersfor refilling)	Sonishield™ employs asoft bottle for ease of use.	Standard bottle
Subject	Other-Sonic™ TransmissionGel	Sonishield™ 100Antimicrobial UltrasoundGel	Ecogel 100Ultrasound Gel
Normal process	Normal process	Sonishield™ productionemploys a closed-loopsystem so there is nopollution transmission.Product is manufacturedvery cleanly	Normal process
Standard production area	Standard production area	Standard production area	Standardproduction area
Standard processmanufactured to releasespecifications.	Standard processmanufactured to releasespecifications.	Standard processmanufactured to releasespecifications.	Standard process
Label	Standard information	Standard information onpolyethylene label toprevent loss of lettering	Standardinformation
Design	Conical cap on bottles. Snaptop cap on Cubitainers.	Bottle diameter designedto be compatible withultrasound device. Bottlecap is designed for ease ofopening and closing withone hand.	Conical cap
Safety	Other-Sonic™ TransmissionGel label containsappropriate warnings andcharacteristics	Sonishield™ label containsappropriate warnings andcharacteristics (Latex free,PVC-free)	Standardinformation
Environmentof Use	Hospital	Hospital	Hospital
TargetPopulation	Pediatric and adult	Pediatric and adult	Pediatric and adult
Use	Multiple Uses	Multiple uses	Multiple uses
Material(Package)	Polyethylene	Polyethylene	Polyethylene
PatientContactMaterials	Probe	Probe	Probe
Energy Type	Electricity only for theultrasound device	Electricity only for theultrasound device	Electricity only forthe ultrasounddevice

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Image /page/6/Picture/11 description: The image is a logo with a stylized letter 'H' inside a rounded square. The 'H' is formed by two vertical lines with a curved element connecting them at the top, resembling a stylized oval. The entire logo, including the 'H' and the square border, is outlined in blue.

Image /page/6/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter 'E' and a star on it. The text on the right reads 'PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING'. The logo appears to be an award or recognition for excellence in exporting.

ghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578

The predicate device 510K (K151070) summary lists Ecogel 100 as not containing dye, while the Konix Ultrasound Gel (K101952) 510K summary, which also used Ecogel 100 as a predicate, lists Ecogel 100 as being dyed green. It is in fact, dyed green.

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Image /page/7/Picture/25 description: The image is a logo with a blue outline of a square. Inside the square is a stylized letter 'H', also in blue. The 'H' is designed with curved lines and has a three-dimensional appearance, with the left and right sides of the 'H' appearing to be slightly offset from each other. An oval shape surrounds the top portion of the 'H', adding to the logo's unique design.

Image /page/7/Picture/3 description: The image shows a logo with a flag on the left side and text on the right side. The flag has the letter "E" and a star on it. The text on the right side says "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

ue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (9

VII. PERFORMANČE DATA

The following performance data was provided in support of the substantial equivalence determination.

Non-clinical performance

Acoustic:

Other-Sonic™ Transmission Gel was evaluated for its acoustic performance. Results indicate that the acoustic properties of the gel are:

1. Virtually identical to that of human skin.
1. Similar to other coupling gels commonly used in the United States.

The acoustic properties of Other-Sonic™ Transmission Gel and Sonishield™ 100 Antimicrobial Ultrasound Gel are as follows:

Property	Other-Sonic™Transmission Gel	Sonishield™ 100AntimicrobialUltrasound Gel
Sound velocity (m/sec)	1601 ms-1 at 22.5°C	1497 ms-1 at 30°C
Density (kg/m3)	1033 kg/ m3 at 22.5°C	1023 kg/ m3 at 30°C
Acoustic impedance (kg/m2 sec)	1.65 MRayls at 22.5°C	1.53 MRayls at 30°C
Attenuation coefficient as a function offrequency, a/f (dB/(cm-MHz)	0.19 + 0.0000105 $f^{2.974}$	0.04 ± 0.0042 $f$

The acoustic properties of the predicate gel and Other-Sonic™ Transmission Gel are virtually identical. Although the analysis was conducted at different temperatures, both are well within the range of temperatures encountered during clinical use (72.5°F - 80°F). Such variations in temperature do not induce more than small changes in the listed acoustic properties, too small to alter performance, or cast doubt upon the conclusions of this comparison.

Antimicrobial Effectiveness Testing:

The USP <51> (Category 2) Antimicrobial Effectiveness Test passed with log reductions greater than 5 for all 14 and 28 day bacterial (Staphylococus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027) counts. Yeasts and molds (Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231) did not increase from initial counts, and in fact considerably decreased.

Animal tests:

Biocompatibility (ISO 10993-10) testing was conducted for Skin Irritation and Skin Sensitization. Conclusions from these studies: Other-Sonic™ Transmission Gel was found to be non-sensitizing and non-irritating.

In Vitro Cytotoxicity:

Cytotoxicity (ISO 10993-5:2009) testing was conducted.

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Image /page/8/Figure/1 description: The image is a logo featuring a stylized letter "H" enclosed within a rounded square frame. The "H" is formed by two vertical lines with curved tops, connected by an oval shape that loops over the top. The entire logo, including the frame and the letter, is outlined in a light blue color, creating a clean and simple design.

Image /page/8/Picture/2 description: The image shows the text "PHARMACEUTICAL INNOVATIONS, INC." in a bold, sans-serif font. The text is a blue color, and the words are stacked on top of each other. There are two horizontal lines below the text.

Image /page/8/Picture/3 description: The image shows a logo with a flag on the left and text on the right. The flag has the letter E on it and a star above it. The text on the right reads "PRESIDENT OF THE UNITED STATES HIGHEST AWARD FOR EXCELLENCE IN EXPORTING".

nghuysen Avenue · Newark, New Jersey 07114-2195 · (973) 242-2900 · Fax: (973) 242-0578

Conclusion from this study: The test article meets the requirement of the test as per The International Organization for Standardization (ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for the In Vitro Cytotoxicity, Reference Number ISO 10993-5:2009), and is not considered cytotoxic.

VIII. CONCLUSIONS

The above-referenced comparisons of the technological and non-clinical performance characteristics indicate that the Other-Sonic™ Transmission Gel is comparable to its predicate and reference devices and certainly substantially equivalent to them and other ultrasonic coupling gels commonly used in the United States today.

Web: www.pharminnovations.com - Email: info@pharminnovations.com

Page 6 of 6

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.