The Aloka ProSound C3 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Aloka ProSound C3cv is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-operative (abdominal, thoracic and PV); Pediatrics, Small Organ (Breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Andominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pedintria; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrects | and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

Device Description

The ProSound C3 is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish), a slight modification of Transmit circuitry, providing a slightly different acoustic profile and the introduction of a spatial compounding feature called OMNIBeam.

The design and construction of the ProSound C3 is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

The ProSound C3cv is a modified version of the Echo/t3000 Ultrasound System. The modifications include a change in the Product Label (of both the systems and the transducers), addition of Foreign language support (French, German, Italian, and Spanish) and the introduction of a spatial compounding feature called OmniBeam.

The design and construction of the ProSound C3cv is similar to the Terason™ Echo/t3000 Ultrasound system. These systems utilize a laptop computer running Windows to run the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. The engine is housed in a compartment that is attached to the bottom of the laptop.

AI/ML Overview

The provided text describes modifications to an ultrasound system (Aloka ProSound C3 and C3cv) and its transducers, and references various non-clinical tests to demonstrate compliance with general safety and performance standards. However, it does not contain information about acceptance criteria for specific imaging performance metrics, nor does it describe studies with sample sizes, expert ground truth, or comparative effectiveness with human readers using AI.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. This is often achieved through non-clinical testing against recognized standards rather than extensive clinical performance studies as would be required for novel devices or AI systems making diagnostic claims.

Therefore, most of the requested information cannot be extracted from this document because such studies were not conducted or described in this regulatory filing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report specific device performance metrics in comparison to such criteria. Instead, compliance is demonstrated through adherence to recognized international and national standards for medical electrical equipment and ultrasonic devices.

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
General Safety	IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety.	The ProSound C3/C3cv systems have been "tested for compliance" with this standard, with specific Intertek Test Record Numbers (e.g., 3157931BOX-001B for C3, 3157931BOX-005A for C3cv) referenced as proof. This implies successful completion of the tests and meeting the requirements, but no quantitative performance data is provided here.
Electrical Systems Safety	IEC 60601-1-1: Medical Electrical Equipment Part 1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems.	"Tested for compliance" with specific Intertek Project references (e.g., 9157933BOX-002A for C3, 9157933BOX-002B for C3cv). Implies successful completion.
	IEC 60601-1-4 (2000): Collateral Standard: Safety Requirements for Medical Electrical Systems. (Note: This is a duplicate or very similar standard to IEC 60601-1-1 listed directly above it in the original text, but listed separately)	"Tested for compliance" with specific Intertek Project references (e.g., 9157933BOX-003A for C3, 9157933BOX-003B for C3cv). Implies successful completion.
Ultrasonic Safety & Performance	IEC 60601-2-37 / EN60601-2-37: Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.	"Tested for compliance" for various transducer models, with specific Intertek Report Numbers referenced for each (e.g., UST-TL01, UST-TL02, UST-TC04, UST-TC05, UST-TC06, UST-TL07 for C3; UST-TL01, UST-TL02, UST-TS03, UST-TC04, UST-TC06, UST-TI09 for C3cv). This indicates that the acoustic output and other safety aspects of the transducers meet the specified requirements. No specific quantitative performance data is provided here.
Acoustic Output Display	NEMA UD 3: Acoustic Output Display.	User Guide (16-5001) for ProSound C3/C3cv is referenced, indicating compliance with NEMA UD 3 for acoustic output display. This is a standard for how acoustic output is presented to the user, not performance itself.
Biocompatibility	ISO 10993 Part 5 and Part 10.	"Biocompatibility reports for all transducers included in this submission" are mentioned, indicating compliance.

Missing Information (Not found in the provided document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information on test sets (beyond compliance testing) for clinical performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test sets with ground truth are described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. AI assistance is not mentioned as a feature of this ultrasound system. The "OMNIBeam" feature is spatial compounding, which is an image processing technique, not an AI diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a diagnostic ultrasound system (hardware and associated software), not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" demonstrated is compliance with engineering and safety standards.
The sample size for the training set: Not applicable. The document does not describe an AI/machine learning component that would require a training set. The software modifications are for foreign language support and spatial compounding (OMNIBeam).
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with established medical device safety and performance standards for an ultrasound system and its transducers. This type of regulatory submission does not typically include detailed clinical performance studies, ground truth establishment, or AI-specific assessment criteria as would be expected for novel diagnostic algorithms. The modifications primarily concern product labeling, foreign language support, a minor transmit circuitry change, and the addition of a spatial compounding feature (OMNIBeam), all of which are assessed for safety and basic functionality rather than intricate diagnostic performance studies with expert ground truth.

Summary

{0}------------------------------------------------

510(k) Summary

K110482

Teratech Corporation

ProSound™ C3 Ultrasound System

MAR 1 8 2011

1. Sponsor:

Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803

Contact Person: Charles F. Hottinger, Ph.D. RAC, Regulatory Affairs Consultant Telephone: 206-780-7945

Date Prepared: October 9, 2010

2. Device Name

Proprietary Name: Aloka ProSound C3 Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer

(21 CFR 892.1570. 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)

3. Predicate Device

Terason™ Echo/t3000 Ultrasound System (K080234)

4. Intended Use

{1}------------------------------------------------

Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

5. Device Description

6. Technology Characteristics

The differences between the ProSound C3 and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:

The engine has a slight modification to the Transmit Chip, providing . different acoustic prodiles. This has been optimized for the ProSound C3 and tested and verified according to the IEC 60601.2.37 standards.
The ultrasound application software has been modified to support foreign . lanquages (French, German, Italian and Spanish). Translations were made for buttons, pulldown menus, text messages, etc. and integrated and tested with the application software.
A new feature, equivalent to spatial compounding, was added to the . application software (since the last 510k submission on the predicate device). This feature, called OMNIBeam in the ProSound C3 is used for better resolution by shooting multiple frames at different angles and combining the image into one. This is offered on only the Linear and Curved transducers.
The System has a different label (Aloka ProSound C3 label) and the . transducers have different names and labels than the predicate device. Other than the labels, the transducers are exactly the same as those used on the Terason Predicate Device.

{2}------------------------------------------------

B1. Non Clinical Tests

The ProSound C3 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

. IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety.
- o Intertek Test Record Number 3157931BOX-001B
. IEC 60601-1-1. Medical Electrical Equipment Part 1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems.
- o Intertek Project: 9157933BOX-002A
IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for ● Medical Electrical Systems
- Intertek Project: 9157933BOX-003A o
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- o Transducer Model UST-TL01: Intertek Report Number 9157931BOX-001M
- Transducer Model UST-TL02: Intertek Report Number o 9157931BOX-001N
- Transducer Model UST-TC04: Intertek Report Number 0 9157931BOX-001Q
- Transducer Model UST-TC05: Intertek Report Number o 9157931BOX-001P
- Transducer Model UST-TC06: Intertek Report Number 0 9157931BOX-001J
- Transducer Model UST-TL07: Intertek Report Number o 9157931BOX-0010
NEMA UD 3 Acoustic Output Display . ProSound C3/C3cv Ultrasound System User Guide (16-5001)

{3}------------------------------------------------

Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
.
Biocompatibility reports for all transducers included in this o submission.

{4}------------------------------------------------

510(k) Summarv

Teratech Corporation

ProSound™ C3cv Ultrasound Svstem

1. Sponsor:

Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803

Contact Person: Charles F. Hottinger, Ph.D. RAC. Regulatory Affairs Consultant Telephone: 206-780-7945

Date Prepared: October 9, 2010

2. Device Name

Proprietary Name: Aloka ProSound C3cv Ultrasound System Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer

(21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)

3. Predicate Device

Terason™ Echo/t3000 Ultrasound System (K080234)

4. Intended Use

{5}------------------------------------------------

Trans-rectal and Trans-vaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

5. Device Description

6. Technology Characteristics

The differences between the ProSound C3cv and the Terason Echo/t3000 Ultrasound System (the predicate device) include the following:

The ultrasound application software has been modified to support foreign . languages (French, German, Italian and Spanish). Translations were made for buttons, pulldown menus, text messages, etc. and integrated and tested with the application software.
· A new feature, equivalent to spatial compounding, was added to the application software (since the last 510k submission on the predicate device). This feature, called OMNIBeam in the ProSound C3cv is used for , better resolution by shooting multiple frames at different angles and combining the image into one. This is offered on only the Linear and Curved transducers.
. The System has a different label (Aloka ProSound C3cv label) and the transducers have different names and labels than the predicate device. Other than the labels, the transducers are exactly the same as those used on the Terason Predicate Device (Terason Echo/t3000).

{6}------------------------------------------------

B1. Non Clinical Tests

The ProSound C3cv system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Safety.
- o Intertek Test Record Number 3157931BOX-005A
IEC 60601-1-1, Medical Electrical Equipment Part 1: General . Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems.
- o Intertek Project: 9157933BOX-002B
IEC60601-1-4 (2000), Collateral Standard: Safety Requirements for � Medical Electrical Systems
- o Intertek Project: 9157933BOX-003B
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- Transducer Model UST-TL01: Intertek Report Number 9157931BOX-005G
- Transducer Model UST-TL02: Intertek Report Number O 9157931BOX-005B
- Transducer Model UST-TS03: Intertek Report Number O 9157931BOX-005C
- Transducer Model UST-TC04: Intertek Report Number O 9157931BOX-005D
- Transducer Model UST-TC06: Intertek Report Number O 9157931BOX-005E
- Transducer Model UST-Ti09: Intertek Report Number ಂ 9157931BOX-005F
. NEMA UD 3 Acoustic Output Display ProSound C3/C3cv Ultrasound System User Guide (16-5001)

{7}------------------------------------------------

Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- o Biocompatibility reports for all transducers included in this submission.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol, with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Teratech Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313

MAR 1 8 2511

Re: K110482

Trade/Device Name: Aloka Prosound C3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 7, 2011 Received: March 8, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the io!!owing transducers intended for use with the Aloka Prosound C3 Ultrasound System, as described in your premarket notification:

Transducer Model Number

UST-TL01	UST-TC05
UST-TL02	UST-TC06
UST-TS03	UST-TL07
UST-TC04	UST-TI09

{9}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.

Sincerely Yours,

Mucy Slastil

Mary S. Pastel. Sc.D Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{10}------------------------------------------------

Indications for Use Form

510(k) Number (if known): ر Device Name: Aloka ProSound C3 Ultrasound System Indications for Use:

Prescription Use: X AND/OR

Over-the-Counter Use:_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110482

Page 1 of _

{11}------------------------------------------------

Indications for Use Form

510(k) Number (if known): Aloka ProSound C3cv Ultrasound System Device Name: Indications for Use:

The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Andominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pedintria; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrects | and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

Prescription Use: × AND/OR

Over-the-Counter Use:__

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postel

Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K116482

Page 1 of __

{12}------------------------------------------------

System: ProSound C3/C3cv Ultrasound Systems

Transducer: (see comments)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetald	P1,4	P2,4	P2,4	P7	P2,4	P2,4	P2,4
	Abdominald:	P1,4	P2,4	P2,4	P7	P2,4	P2,4	P2,4
	Intra-operative (Spec.)d,e	P4,8	P4,8	P4,8		P4,8	P4,8	P4,8
	Intra-operative (Neuro)	P5	P5	P5		P5	P5	P5
	Laparoscopic	P6	P6	P6		P6	P6	P6
	Pediatricd:	P1,4	P2,4	P2,4	P7	P2,4	P2,4	P2,4
	Small Organ (Thyroid,Breast, Testes, etc.)d:	P2,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Neonatal Cephalicd:	P1,4	P2,4	P2,4	P7	P2,4	P2,4	P2,4
	Adult Cephalicd:	P1,4	P2,4	P2,4	P7	P2,4	P2,4	P2,4
	Trans-rectalf:	P2-4	P3-4	P3-4		P3-4	P3-4	P3-4
	Trans-vaginalg:	P2-4	P3-4	P3-4		P3-4	P3-4	P3-4
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:	P2,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Musculo-skel. (Superfic)g:	P2,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P1,8	P2,8	P2,8	P7,8	P2,8	P2,8	P2,8
	Cardiac Pediatric	P1,8	P2,8	P2,8	P7,8	P2,8	P2,8	P2,8
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselg:	P1,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234); E= added under Appendix E

ª includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).

° B+M: B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

9 Incl. ultrasound guidance for placement of needles, catheters

Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Incl. guidance of amniocentesis, infortility monitoring of follicle development.

' Incl. stress echo.

System uses previously cleared under K992505 with 3MHz Model L3 (Linear)

2 System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

5 System uses previously cleared under K040840

6 System uses previously cleared under K043278

7 System uses previously cleared under K051334

8 System uses previously cleared under K080234

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Postl

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K110482

{13}------------------------------------------------

System: ProSound C3/C3cv Ultrasound System

Transducer: UST-TL01

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
Ophthalmic	Ophthalmic
	Fetalf
	Abdominald:	E	E	E		E	E	E
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricc:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)d:	E	E	E		E	E	E
	Neonatal Cephalicc:	E	E	E		E	E	E
	Adult Cephalicc:	E	E	E		E	E	E
	Trans-rectall:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)g:	E	E	E		E	E	E
	Musculo-skel. (Superfic)g:	E	E	E		E	E	E
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral vesselg:	E	E	E		E	E	E
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

° Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).

8 B+M; B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

9 Incl. ultrasound guidance for placement of needles, catheters

Abdominal organs and peripheral vessel.

1 Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Incl. guidance of amniocentesis, infertility monitoring of follicle development.

Incl. stress echo.

1 System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

్ System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

్ System uses previously cleared under K040840

్ System uses previously cleared under K043278

' System uses previously cleared under K051334

8 System uses previously cleared under K080234

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Postel

Division Sign-Up
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K11482

{14}------------------------------------------------

System:	ProSound C3/C3cv Ultrasound System
---------	------------------------------------

Transducer: UST-TL02

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalf
	Abdominalc:	E	E	E		E	E	E
	Intra-operative (Spec.)d,a
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricc:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)d:	E	E	E		E	E	E
	Neonatal Cephalicc:	E	E	E		E	E	E
	Adult Cephalicc:	E	E	E		E	E	E
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)c:	E	E	E		E	E	E
	Musculo-skel. (Superfic)g:	E	E	E		E	E	E
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessele:	E	E	E		E	E	E
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

ී Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+OPD; B+PD

° Harmonic Imaging (Hi)

9 Incl. ultrasound guidance for placement of needles, catheters

° Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Incl. guidance of amniocentesis, infertility monitoring of follicle development.

Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

2 System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

System uses previously cleared under K040840

్ System uses previously cleared under K043278

System Less proviously cleared under K011334

System uses previously cleared under K081004

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division Sign-Up
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)

10482

{15}------------------------------------------------

System: ProSound C3cv Ultrasound System_

Transducer: UST-TS03

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetaln	E	E	E		E	E	E
	Abdominalo:	E	E	E		E	E	E
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatrico:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)o:	E	E	E		E	E	E
	Neonatal Cephalico:	E	E	E		E	E	E
	Adult Cephalico:	E	E	E		E	E	E
	Trans-rectalp:
	Trans-vaginalp:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)o:
	Musculo-skel. (Superfic)o:
	Intra-luminal
	Other (Specify)
	Cardiac Adult	E	E	E	E	E	E	E
Cardiac	Cardiac Pediatric	E	E	E		E	E	E
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselo:
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).

฿ B+M; B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

8 Incl. ultrasound guidance for placement of needles, catheters

° Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" incl. guidance of amniocentesis, infertility monitoring of follicle development.

' Incl. stress echo.

1 System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

System uses previously cleared under K040840

్ System uses previously cleared under K043278

7 System uses previously cleared under K051334

System uses previously cleared under K080234

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Stodd
Division Sign Off

Division Sign-Off/
Office of In Vitro Diagnostic Device
Evaluation, and Safety
Blacien

510(k) K110482

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

{16}------------------------------------------------

ProSound C3/C3cv Ultrasound System_ System:

Transducer: UST-TC04

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetaln	E	E	E		E	E	E
	Abdominald:	E	E	E		E	E	E
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricc:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)d:
	Neonatal Cephalicc:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:
	Musculo-skel. (Superfic)g:
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselc:	E	E	E		E	E	E
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

ª Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).

° B+M; B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

Incl. ultrasound guidance for placement of needles, catheters

· Abdominal organs and peripheral vessel.

' incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Incl. guidance of amniocentesis, infertility monitoring of follicle development.

' Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

" System uses previously cleared under K052303
" System uses previously cleared under K012191
" System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K010000
System uses previously cleared under K030191

్ System uses previously cleared under K040840

్ System uses previously cieared under K043278

' System uses previously cleared under K051334

® System uses previously cleared under K080234

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pitaf
Division Sign Off

fice of In Vitro Diagnostic Device

(k) K110 c/82

Page 1 of

{17}------------------------------------------------

System: ProSound C3 Ultrasound System_

Transducer: UST-TC05

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetaln	E	E	E		E	E	E
	Abdominalc:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatricc:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)d:	E	E	E		E	E	E
	Neonatal Cephalicc:	E	E	E		E	E	E
	Adult Cephalicc:	E	E	E		E	E	E
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:
	Musculo-skel. (Superfic)d:
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	E	E	E		E	E	E
	Cardiac Pediatric	E	E	E		E	E	E
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessele:	E	E	E		E	E	E
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

ª Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). ° B+M; B+PWD; B+CD; B+OPD; B+PD

° Harmonic Imaging (HI)

9 Incl. ultrasound guidance for placement of needles, catheters

· Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Incl. guidance of amniocentesis, infertility monitoring of follicle development.

' Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

System uses previously cleared under K012191

3 System uses previously cleared under K010883

4 System uses previously cleared under K030191

్ System uses previously cleared under K040840

§ System uses previously cleared under K043278

T System uses previously cleared under K051334

" System uses proviously cleared under K081004

System uses previously cleared under K080234

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil
Division Sign Off

510(k) K110482

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

{18}------------------------------------------------

System: ProSound C3/C3cv Ultrasound System____________________________________________________________________________________________________________________________________________

Transducer: UST-TC06

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetaln	E	E	E		E	E	E
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:
	Small Organ (Thyroid,Breast, Testes, etc.)d:
	Neonatal Cephalico:
	Adult Cephalica:
	Trans-rectalf:	E	E	E		E	E	E
	Trans-vaginalg:	E	E	E		E	E	E
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:
	Musculo-skel. (Superfic)e:
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselc:
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

් Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD).

6 B+M, B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

4 Incl. ultrasound guidance for placement of needles, catheters

· Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follice development.

1 Incl. guidance of amniocentesis, infertility monitoring of follicle development.

Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

{ System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

5 System uses previously cleared under K040840

6 System uses previously cieared under K043278

7 System uses previously cleared under K051334

® System uses previously cleared under K080234

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Pastil
Division Sign Off

ice of In Vitro Diagnostic Device

510(k) K110482

Page 1 of _

{19}------------------------------------------------

System: ProSound C3 Ultrasound System_

Transducer: UST-TL07

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalf
	Abdominalc:
	Intra-operative (Spec.)d,e	E	E	E		E	E	E
	Intra-operative (Neuro)	E	E	E		E	E	E
	Laparoscopic	E	E	E		E	E	E
FetalImaging& Other	Pediatricc:	E	E	E		E	E	E
	Small Organ (Thyroid,Breast, Testes, etc.)d:	E	E	E		E	E	E
	Neonatal Cephalicc:
	Adult Cephalicc:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)c:	E	E	E		E	E	E
	Musculo-skel. (Superfic)c:	E	E	E		E	E	E
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselc:	E	E	E		E	E	E
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

ª Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

9 Incl. ultrasound guidance for placement of needles, catheters

ª Abdominal organs and peripheral vessel.

' Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Incl. ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

11 Incl. guidance of amniocentesis, infertility monitoring of follicle development.

'Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

System uses previously cleared under K012191

3 System uses previously cleared under K010883

System uses previously cleared under K030191

System uses previously cleared under K000191
System uses previously cleared under K040840

& System uses previously cleared under K040040
P =

? System uses previously cleared under K051334

& System uses previously cleared under K080234

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division Sign Office of In Vitro Diagnostic Device Evaluation and Safe

Evaluation and Safety
510(k) K110482

Page 1 of _

{20}------------------------------------------------

System: ProSound C3cv Ultrasound System_

Transducer: UST-TI09

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetaln
	Abdominalc:
	Intra-operative (Spec.) d.e.)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricc:
	Small Organ (Thyroid,Breast, Testes, etc.)q:
	Neonatal Cephalicc:
	Adult Cephalicc:
	Trans-rectall:
	Trans-vaginals:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)q:
	Musculo-skel. (Superfic)q:
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult				E
	Cardiac Pediatric				E
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vesselc:
	Other (Specify)

N= new indication; P= previously cleared by FDA (incl. K080234; E= added under Appendix E

4 Includes Color Dopp. (CD), Directional Power Dopp. (DPD), and (non-directional) Power Dopp. (PD). 6 B+M; B+PWD; B+CD; B+DPD; B+PD

° Harmonic Imaging (HI)

° Incl. ultrasound guidance for placement of needles, catheters

· Abdominal organs and peripheral vessel.

in bestimal organs and polipheral voods.
"Incl. ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

& Incl. ultrasound guidance of transvaginal biopsy, intertility monitoring of follicle bevelopment.

" Incl. guidance of amniocentesis, infertility monitoring of follicle development.

' Incl. stress echo.

System uses previously cleared under K992505 with 3MHz. Model L3 (Linear)

² System uses previously cleared under K012191

3 System uses previously cleared under K010883

4 System uses previously cleared under K030191

System uses previously cleared under K000130
System uses previously cleared under K040840

్ System uses previously cleared under K043278

' System uses previously cleared under K045276
' System uses previously cleared under K051334
I o

8 System uses previously cleared under K080234

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

of In Vitro Diagnostic Device

Evaluation and Safety
510(k) K110482

Page 1 of __

Regulation Number and Section

§ 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.