The Viamo SSA-640 v2.0 Ultrasound System is indicated for the visualization of structures, characteristics, 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, trans-vaginal neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculoskeletal (both conventional and superficial).

Device Description

The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 12 MHz.

AI/ML Overview

The provided text describes the Toshiba Viamo SSA-640A Ultrasound System (v2.0), cleared under 510(k) K100067. This submission is for an ultrasound device and its various transducers, and as such, the document does not contain acceptance criteria, detailed study designs (test set, training set, ground truth, expert qualifications, or adjudication methods), or performance metrics typically associated with AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices.

Ultrasound systems are cleared based on substantial equivalence to predicate devices, demonstrating that they are as safe and effective. The clearance process for such devices typically involves:

Conformance to standards: Demonstrating compliance with recognized electrical safety, electromagnetic compatibility, and acoustic output standards (e.g., IEC 60601-1, AIUM-NEMA UD2, UD3).
Performance testing: Verifying that the system and its transducers meet specified technical and imaging performance parameters (e.g., image resolution, penetration, uniformity, Doppler accuracy). These tests are usually conducted in-house by the manufacturer and are not usually detailed in summary documents like 510(k) summaries.
Comparison to predicate device: Providing evidence that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, the specific information requested in the prompt (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) is not typically found in a 510(k) summary for a general diagnostic ultrasound system. This type of information is more relevant for AI/Machine Learning-enabled medical devices or those with specific diagnostic claims where performance against a clinical ground truth is central to the clearance.

If this were an AI/CADe/CADx device, here's how the information would be presented, based on common regulatory expectations (but this information is not in the provided text):

Acceptance Criteria and Device Performance for an AI/CADe/CADx Device (Hypothetical, not from the provided text)

The provided 510(k) summary (K100067) is for a general diagnostic ultrasound system and its transducers. It does not include specific acceptance criteria or performance studies in the context of AI/CADe/CADx devices. Ultrasound systems are typically cleared based on demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards for safety and performance (e.g., image quality, acoustic output).

Therefore, the following sections are hypothetical, illustrating what would be expected for an AI/CADe/CADx device making specific diagnostic claims, rather than a general imaging system.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

Performance Metric	Acceptance Criteria (e.g., for specific clinical task)	Reported Device Performance (e.g., from clinical study)
Sensitivity	≥ 90% for detecting [condition X]	92% (95% CI: 89-94%)
Specificity	≥ 80% for detecting [condition X]	83% (95% CI: 80-85%)
AUC	≥ 0.90 for distinguishing [condition X] from normal	0.93 (95% CI: 0.91-0.95)

2. Sample Size and Data Provenance for Test Set (Hypothetical)

Sample Size (Test Set): Typically, hundreds to thousands of cases are used, depending on the prevalence of the condition and endpoint variability. For example, 500 cases (250 positive, 250 negative).
Data Provenance: Retrospective, multi-site data from [e.g., multiple hospitals in the United States, Europe, and Asia]. Cases selected to ensure diversity in patient demographics, disease presentation, and image quality.

3. Number and Qualifications of Experts for Ground Truth (Hypothetical)

Number of Experts: 3-5 independent experts.
Qualifications: Board-certified radiologists with 5-15 years of experience specializing in [e.g., abdominal, fetal, small organ] ultrasound imaging.

4. Adjudication Method for Test Set (Hypothetical)

Adjudication Method: 2+1 adjudication. Initial assessment by two experts; if their assessments differed, a third senior expert would resolve the discrepancy. Unanimous agreement (or majority agreement for three experts) established the final ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)

Was an MRMC study done? Yes.
Effect Size (Human Readers with vs. without AI Assistance):
- Improvement in AUC: Readers improved their diagnostic accuracy (measured by AUC) by an average of 0.05 (e.g., from 0.85 without AI to 0.90 with AI). This translates to a [e.g., 5.9%] relative improvement in AUC.
- Improvement in Sensitivity: Average sensitivity increased by [e.g., 8 percentage points] (e.g., from 82% to 90%).
- Reduction in False Positives: Average false positive rate decreased by [e.g., 10%] (e.g., from 25% to 15%).
- Reading Time Reduction: Average reading time per case decreased by [e.g., 20%].

6. Standalone Performance Study (Hypothetical)

Was a standalone study done? Yes.
Standalone Performance: The algorithm achieved a standalone sensitivity of 91% and a specificity of 82% on the independent test set, with an AUC of 0.92.

7. Type of Ground Truth Used (Hypothetical)

Type of Ground Truth: Established through expert consensus (as described in section 3 & 4), cross-referenced with confirmatory pathology reports and/or long-term patient outcomes where available.

8. Sample Size for Training Set (Hypothetical)

Sample Size (Training Set): Typically tens of thousands to hundreds of thousands of images/cases, depending on the complexity of the task and the diversity of the data required. For example, 50,000 cases (25,000 positive, 25,000 negative) from diverse sources.

9. How Ground Truth for Training Set Was Established (Hypothetical)

Ground Truth Establishment for Training Set: Ground truth was established by a team of trained medical professionals (e.g., sonographers, residents, and attending physicians), often using a single-reader read or two-reader consensus, with a more rigorous multi-expert adjudication applied to a subset of challenging cases or for quality control. Data was also verified against available patient records, pathology, or clinical follow-up.

Summary

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K100067

510(k) Premarket Notification Viamo (2.0) SSA-640A Ultrasound System

510(k) Summary

Submitter's Name:	Toshiba America Medical Systems, Inc.	JAN 2 8 2010
Address:	2441 Michelle Drive, Tustin, CA 92780
Contact:	Paul Biggins, Director Regulatory Affairs
Telephone No .:	(714) 730-5000

Device Proprietary Name:	VIAMO MODEL SSA-640A Version 2.0-
Common Name:	Diagnostic Ultrasound System

Classification:

. Regulatory Class: II
Review Category: Tier II . ●
. Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg.No .: 892.1550]
. Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg.No .: 892.1560]
. Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No .: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

Toshiba Ultrasound Diagnostic System Viamo Model SSA-640 v1.2 510(k) K093171 .
Toshiba Ultrasound Diagnostic System Aplio XG Model SSA-790A V4.0 510(k) K091295 .

Device Description:

Intended Use:

Declaration of Conformity:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 2 8 2010

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K100067

Trade/Device Name: Viamo SSA-640 v2.0 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: January 8, 2010 Received: January 11, 2010

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 following transducers intended for use with the Viamo SSA-640 v2.0 Ultrasound System, as described in your premarket notification:

Transducer Model Number

PLT-704AT	PVT-674BT	PLT-704ST
PVT-705BTH	PLT-1204BT	PVT-375ST
PVT-745BTV	PVT-382BT	PST-25ST
PVT-661VT	PLT-805AT

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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 (1 vire 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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/CDRH/CDRHOffices/uccn1118000.html 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 Paul Hardy at (301) 796-6542.

Sincerely yours.

Donald J. Trump

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known): K100067

Device Name: Viamo SSA-640 v2.0 Ultrasound System

Indications for Use:

The Viamo SSA-640 v2.0 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes with the human body using ultrassund on survivide mage information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, smill organs, trans-vaginal, neonatal cephalic, cardiac, cardiac, cardiac, peripheral vascular, and musculo-sketal (both conventional and superficial).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 Diagnostic Devices (OIVD) . tt

(Division Sign-Off) Division of Radiological Devices

510(k) Number

Page 1 of

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510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v2.0 SSA-640A

Transducer:

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify) *	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal	P	P	P	P	P	2	P	N	P	3
Abdominal	P	P	P	P	P	2	P	N	P	3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	2	P	N	P	3
Small Organ (Note 1)	P	P	P	P	P	2	P	N	P	3
Neonatal Cephalic	P	P	P	P	P	2	P	N	P	3
Adult Cephalic	P	P	P	P	P	2	P	N	P	3
Trans-rectal										3
Trans-vaginal	N	N	N	N	N	2	N	N	N	3
Trans-urethral									N	3
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P	P	P	2	P	N	P	3
Musculo-skeletal (Superficial)	P	P	P	P	P	2	P	N	P	3
Intravascular										3
Other (Specify)
Cardiac Adult	P	P	P	P	P	2	P	N	P	3
Cardiac Pediatric	P	P	P	P	P	2	P	N	P	3
Intravascular (Cardiac)										3
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	P	2	P	N	P	3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k): K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure: added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number K100827

B-2

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System: Viamo v2,0 SSA-640A Transducer:_ PST-25ST

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	2	P	N	P	3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	N	P	3
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	2	P	N	P	3
Adult Cephalic	P	P	P	P	2	P	N	P	3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult	P	P	P	P	2	P	N	P	3
Cardiac Pediatric	P	P	P	p	2	P	N	P	3
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number

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510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v2.0 SSA-640A PVT-375ST Transducer:_

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	N	P			3
Abdominal	P	P	P		P	2	P	N	P			3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	N	P			3
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

R.A.R

(Division Sign-Off) Division of Radiological Devices

510(k) Number frood

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510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v4.0 SSA-640A Transducer: PLT-704ST

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	N	P			3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	2	P	N	P			3
Musculo-skeletal (Superficial)	P	P	P		P	2	P	N	P			3
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	N	P			3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/ BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number_k) 00017

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System: Viamo v2.0 SSA-640A Transducer: PLT-805AT

: ১

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	Color.Doppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	2	P	N	P	3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P	P	2	P	N	P	3
Musculo-skeletal (Superficial)	P	P	P	P	2	P	N	P	3
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	N	P	3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K093171

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

DHD

(Division Sign-Off) Division of Radiological Devices

510(k) Number_ #100067

. ' 。

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System: Viamo v2.0 SSA-640A Transducer: PVT-382BT

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

Clinical ApplicationSpecific(Tracks 3)	B	M	PWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal	P	P	P	P	2	P	N	P	3
Abdominal	P	P	P	P	2	P	N	P	3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	2	P	N	P	3
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091371

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/PWD; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

ty B

(Division Sign-Off) Division of Radiological Devices

510(k) Number K160647

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System: _ Viamo v2.0 SSA-640A Transducer:_ PLT-1204BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P		P	2	P	N	P			3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	N	P			3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

D.H.R.

(Division Sign-Off) Division of Radiological Devices

510(k) Number $k_{1} 00067$

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Viamo v2.0 SSA-640A System: Transducer: PVT-674BT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal	P	P	P		P	2	P	N	P			3
Abdominal	P	P	P		P	2	P	N	P			3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	2	P	N	P			3
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix = Previous 510(k) of the transducer: K091295

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BIM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/ BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

2012

(Division Sign-Off) Division of Radiological Devices

510(k) Number K/r∂∂<7

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510(k) Premarket Notification Viamo (v2.0) SSA-640A Ultrasound System

System: Viamo v2.0 SSA-640A Transducer: PVT-661VT

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal	N	N	N	N	N	2		N	N	N			3
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number K10067

。「

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

System: _ Viamo v2.0 SSA-640A Transducer:_ PVT-745BTV

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

Clinical Application
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P		P	2	P	N	P			3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P		P	2	P	N	P			3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

K.E.O.R

(Division Sign-Off) Division of Radiological Devices

510(k) Number K100067

B-11

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

System: Viamo v2.0 SSA-640A Transducer:_ PVT-705BTH

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

Clinical Application	Mode of Operation
Specific(Tracks 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	CHI2D	3D	Other[Note]
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	2	P	N	P			3
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous S10(k) of the transducer: K091295

Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number K/800 67

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

System: Viamo v2.0 SSA-640A Transducer:_ PLT-704AT

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

Clinical ApplicationSpecific(Tracks 3)	Mode of Operation			ColorDoppler	Combined(Specify)*	THI	AdvancedDynamicFlow	Power	Other[Note]
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) (1)	P	P	P	P	2	P	N	P	3
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel	P	P	P	P	2	P	N	P	3
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295

Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD Note 3 ApliPure : added under this submission

Prescription Use Only (Per 21 CRF801.109)

signature

(Division Sign-Off) Division of Radiological Devices

510(k) Number K 100067

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.