Viamo c100 TUS-VC100 Diagnostic Ultrasound System

• K Number: K173962
• Device Name: Viamo c100 TUS-VC100 Diagnostic Ultrasound System
• Manufacturer: Toshiba Medical Systems Corporation
• Date Cleared: 2018-04-20 ( 113 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K170374
• Predicate For: N/A

Intended Use

The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.

Device Description

The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is an integrated, preprogrammed, color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes and 3D/4D.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Toshiba Medical Systems Corporation Viamo c100 TUS-VC100 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, the document explicitly states, "No clinical testing was required."

However, it does detail non-clinical tests conducted to ensure safety and effectiveness.

Here's a breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed to establish performance metrics against specific acceptance criteria for diagnostic accuracy, a direct table of clinical acceptance criteria and reported device performance cannot be generated.

However, the non-clinical acceptance criteria are based on conformance to established medical device safety standards. The reported performance is that the device was found to conform to these standards.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Electrical Safety: Conformance to IEC 60601-1:2005	Device found to conform to the standard.
Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2:2007	Device found to conform to the standard.
Ultrasonic Medical Diagnostic Equipment Safety: Conformance to IEC 60601-2-37:2007	Device found to conform to the standard.
Acoustic Output Measurement: Conformance to NEMA UD 2-2004	Device found to conform to the standard.
Real-time Display of Thermal and Mechanical Acoustic Output Indices: Conformance to NEMA UD3:2004	Device found to conform to the standard.
Biocompatibility: Conformance to ISO 10993-1:2009	Device found to conform to the standard.
Software Validation: Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" (May 11, 2005)	Successful completion of software validation.
Risk Management and Design Controls: Application of established principles (21 CFR § 820 and ISO 13485 Standards)	Application of risk management and design controls.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No clinical test set was used. The submission states "No clinical testing was required." The evaluation was based on non-clinical tests demonstrating conformance to safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Since no clinical testing was performed, there was no need for experts to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set was used, therefore no adjudication method was employed.

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

• Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hardware-based diagnostic ultrasound system, not an algorithm being tested for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground truth (for non-clinical tests): The "ground truth" for the non-clinical tests was the established requirements and specifications within the referenced international and national safety standards (IEC, NEMA, ISO). Conformance to these standards served as the "ground truth" for demonstrating the device's safety and fundamental performance characteristics.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory clearance for a diagnostic ultrasound system, not an AI/machine learning model that would require a training set.

9. How the ground truth for the training set was established

• Not applicable. As no training set was used (see point 8), there was no ground truth to establish for it.

Summary

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

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

April 20, 2018

Re: K173962

Trade/Device Name: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 22, 2018 Received: March 23, 2018

Dear Mr. Tadeo:

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.

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

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

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

Enclosure

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

Indications for Use

510(k) Number (if known)

K173962

Device Name

Viamo c100 TUS-VC100 Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------	-----------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

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

Diagnostic Ultrasound Indications For Use

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System

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

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	3
	Abdominal	N	N	N		N	N	N	4,5
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N
	Small Organ[1] (Specify)	N	N	N		N	N	N	2,4,5
	Neonatal Cephalic	N	N	N	N	N	N	N	4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	4,5,6
	Trans-rectal	N	N	N		N	N	N	5
	Trans-vaginal	N	N	N		N	N	N	5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5
	Other (Urology)	N	N	N		N	N	N	4,5
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	4,5,6
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	4,5

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note : 1. Combined modes are B+M, B+CFM ,B+PW , CW, B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Small Organ: thyroid, testes, breast

3.4D

4. Includes guidance of biopsy (2D)

5. THI

6. TDI

Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N
	Abdominal	N	N	N		N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ1 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Small Organ: thyroid, testes, breast

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _ _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-704ST

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

Clinical Application			Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	3,4
	Small Organ[1] (Specify)	N	N	N	N	N	N	N	2,3.4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	3,4
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	3,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	3.4

N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Small Organ: thyroid, testes, breast

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _ メ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-1204ST

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,4
	Small Organ[1] (Specify)	N	N	N		N	N	N	2,3,4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	3,4
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	3,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,4

N = new indication; P = previously cleared by FDA;

Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Small Organ: thyroid, testes, breast

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _ メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

E = added under this appendix

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-805ST

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	3,4
	Small Organ[1] (Specify)	N	N	N		N	N	N	2,3,4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	3,4
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	3,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,4

N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Small Organ: thyroid, testes, breast

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System PLU-1003ST Transducer:

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)	N	N	N		N	N	N	2,3,4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	3,4
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	3,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	3,4

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Small Organ: thyroid, testes, breast

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PLU-704RST

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	3
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	2,3
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Includes guidance of biopsy (2D)

3. THI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-621VST

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	3
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	2,3
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Includes guidance of biopsy (2D)

3. THI

Prescription Use _ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-781VST

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	3
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	2,3
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Includes guidance of biopsy (2D)

3. THI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PSU-30ST

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	2,3,4
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note : 1. Combined modes are B+M. B+CFM ,B+PW , CW , B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Includes guidance of biopsy (2D)

3. THI

4. TDI

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Viamo c100 TUS-VC100 Diagnostic Ultrasound System System: PSU-60ST Transducer:

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	2,3,4
	Transesophageal
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B+M, B+CFM ,B+PW , CW , B+Color M, B/BC,B+CFM+PW ,B+PDI or DPD+PW 2. Includes guidance of biopsy (2D)

3. THI

4. TDI

Prescription Use メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-682ST

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	2,3
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	2,3
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW, B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. Includes guidance of biopsy (2D)

3. THI

Prescription Use __ × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PC-20ST

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Transesophageal
Peripheral Vessel	Peripheral vessel				N

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

N = new indication;

P = previously cleared by FDA;

E = added under this appendix

× Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System: Viamo c100 TUS-VC100 Diagnostic Ultrasound System Transducer: PVU-574MST

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	2
	Abdominal	N	N	N		N	N	N	3,4
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	3,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication; E = added under this appendix Note : 1. Combined modes are B+M, B+CFM ,B+PW , B/BC,B+CFM+PW ,B+PDI or DPD+PW

2. 4D

3. Includes guidance of biopsy (2D)

4. THI

Prescription Use _____________________________________________________________________________________________________________________________________________________________ メ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Image /page/17/Picture/0 description: The image shows the logo for Toshiba Medical. The words "TOSHIBA" and "MEDICAL" are stacked on top of each other. Both words are written in a bold, sans-serif font and are colored red.

510(k) SUMMARY

• 1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
• OFFICIAL CORRESPONDENT 2. Naofumi Watanabe
• 3. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 [phone]

• 5. Date Prepared: December 27, 2017

6. TRADE NAME(S): Viamo c100 TUS-VC100 Diagnostic Ultrasound System

COMMON NAME: 7.

System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:

Class II

Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

TOSHIBA AMERICA MEDICAL SYSTEMS

Image /page/17/Picture/16 description: The image contains the logo for Canon Group. The word "Canon" is written in red, with a stylized font. Below the word "Canon", the words "CANON GROUP" are written in a smaller, sans-serif font. The logo is simple and recognizable.

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

9. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
SonoBook Series DiagnosticUltrasound System	CHISON MedicalTechnologies Co., Ltd.	K170374	June 6, 2017

10. REASON FOR SUBMISSION:

New device

11. DEVICE DESCRIPTION:

The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is an integrated, preprogrammed, color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time.

The probes provided with this system are electrical-acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. lts basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes and 3D/4D.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, thyroid, testes), transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.

13. SUBSTANTIAL EQUIVALENCE:

The subject device is substantially equivalent to the SonoBook Series Diagnostic Ultrasound System, K170374, marketed by CHISON Medical Technologies Co., Ltd. The Viamo c100 `TUS-VC100 Diagnostic Ultrasound System functions in a manner similar to and is intended for the same use as the predicate device. The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is similar to the predicate device in all aspects except it does not include transesophageal clinical applications, Elastography, B+PW/CW or B+CFM+PW/CW display modes.

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

Product NameK number	SonoBook SeriesDiagnostic Ultrasound SystemK170374	Viamo c100 TUS-VC100Diagnostic Ultrasound SystemThis submission	Comments
ClinicalApplications	Fetal, Abdominal, Pediatric,Small Organ (breast, thyroid,testes) Neonatal Cephalic, AdultCephalic, Cardiac (adult,pediatric), Musculo-skeletal(Conventional, Superficial)Peripheral Vascular,Transesophageal, Trans-rectal,Trans-vaginal, Urology	Fetal, Abdominal, Pediatric,Small Organ (breast, thyroid,testes) Neonatal Cephalic, AdultCephalic, Cardiac (adult,pediatric), Musculo-skeletal(Conventional, Superficial)Peripheral Vascular, Trans-rectal,Trans-vaginal, Urology	Subject devicedoes not includeTransesophagealclinicalapplication
OperationMode	B, FHI,B/M, M, Color M, FreeSteering M ,CFM,PW,PDI,DPD,CW, 3D/4D ,Elastography, TDI, CurvedPanoramic ,Trapezoidal image,Compound Imaging	B, THI,B/M, M, Color M, FreeSteering M CFM,PW,PDI,DPD,CW, 3D/4D , TDI,Curved Panoramic ,Trapezoidalimage, Compound Imaging	Subject devicedoes not haveElastographyoperation mode
Display Modes	B, 2B,4B, B/M ,M,TDI,3D/4D,CWB/BC,B/M, B+Color M,B+PW/CW,B+CFM, B+PDI/DPD,B+CFM+PW/CW,B+ PDI/DPD+PW	B, 2B,4B, B/M ,M,TDI,3D/4D,CWB/BC,B/M, B+Color M,B+PW,B+CFM, B+PDI/DPD,B+CFM+PW,B+ PDI/DPD+PW	Subject devicedoes not includeB+PW/CW,B+CFM+PW/CWdisplay modes
DisplayMonitor	15" high-resolution color LCDmonitor	15" high-resolution color LCDmonitor	Same
Measurements	2D mode: Depth, Distance,Area: Ellipse, Trace, Spline,Trace Length, Volume: Distance,Ellipse, Ellipse + Distance,Distance Ratio, Area Ratio, IMT,Volume Flow,M mode: Distance, Time, HeartRate, Velocity;Doppler mode: D Velocity, Time,Heart Rate, Acceleration, DTrace, S/D, Volume Flow;	2D mode: Depth, Distance,Area: Ellipse, Trace, Spline,Trace Length, Volume: Distance,Ellipse, Ellipse + Distance,Distance Ratio, Area Ratio, IMT,Volume Flow,M mode: Distance, Time, HeartRate, Velocity;Doppler mode: D Velocity, Time,Heart Rate, Acceleration, DTrace, S/D, Volume Flow;	Same
TransducerTypes &Connectors	Convex Array, Phased Array,Linear Array, Volume probe1ports	Convex Array, Phased Array,Linear Array, Volume probe1ports	Same
AcousticOutput	Derated ISPTA: 720mW/cm2maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm2maximum	Derated ISPTA: 720mW/cm2maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm2maximum	Same

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

14. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 (2005), IEC60601-1-2 (2007), IEC 60601-2-37 (2007), NEMA UD 2, NEMA UD3, and ISO 10993-1 standards.

15. TESTING

Non-Clinical Tests

The Viamo c100 TUS-VC100 Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.

IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

Clinical Tests

No clinical testing was required.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

16. CONCLUSION

The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is substantially equivalent to the predicate device. The subject device functions in a manner similar to and is intended for the same use as the predicate device, as described in the labeling. Based upon the bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.

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.