SSA-770A, APLIO VERSION 5.5 by TOSHIBA MEDICAL SYSTEMS CORPORATION

The APLIO is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial) and laparoscopic.

Device Description

The APLIO Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

AI/ML Overview

This is a 510(k) premarket notification for an ultrasound system, not a study evaluating an AI device or a diagnostic test. Therefore, the traditional acceptance criteria and study design details often found in submissions for AI/ML-enabled devices or new diagnostic tests are not explicitly present in the provided document.

The document primarily focuses on establishing substantial equivalence to previously cleared devices for various clinical applications and operational modes of the Toshiba APLIO Ultrasound System (SSA-770A) and its associated transducers. The "acceptance criteria" here refer to the regulatory requirement of demonstrating that the device is as safe and effective as a legally marketed predicate device. The "study" described is the 510(k) submission process itself, which relies on comparison to predicate devices and adherence to relevant industry standards and regulations.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size and ground truth) are not applicable in the context of this 510(k) submission as it is not a performance study for a novel algorithm or diagnostic metric.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices, adhering to recognized standards, and ensuring the device's technical specifications and intended uses fall within acceptable parameters for diagnostic ultrasound systems. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices for the specified indications.

The tables within the document describe the intended clinical applications and modes of operation for the SSA-770A system and each of its transducers. A "P" indicates "Previously Cleared by FDA" for that application/mode, while "E" indicates "Added under Appendix E (LTF)" (likely referring to the FDA's "Least Technologically Advanced" guidance for substantial equivalence). This means the device meets the "acceptance criteria" for these applications by demonstrating they are equivalent to or derived from previously cleared functionalities.

Clinical Application (System SSA-770A)	Mode of Operation (Examples)	Equivalence Status
Fetal	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Abdominal	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Intraoperative	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various)	P
Pediatric	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Small Organ (Thyroid, breast, etc.)	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Neonatal Cephalic	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Adult Cephalic	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 RSI, TDI-Q	P
Cardiac	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 Harmonic, 1.5 RSI, TDI-Q	P, E
Transesophageal	B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging, 1.5 Harmonic, TDI-Q	P, E
Transrectal	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging	P
Transvaginal	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging	P
Peripheral Vascular	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging	P
Laparoscopic	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various)	P
Musculo-skeletal	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging	P
Musculo-skeletal Conventional	B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Various), Harmonic Imaging	P

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

Not Applicable. This document is a 510(k) premarket notification for an ultrasound system, not a clinical performance study with a test set of patient data. The regulatory approval is based on substantial equivalence to predicate devices and adherence to relevant standards for diagnostic ultrasound. There is no mention of a specific "test set" of patient data in the context of validating algorithmic performance.

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. As per point 2, there is no explicit test set or ground truth establishment by experts described in this 510(k) submission.

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

Not Applicable. As per point 2, no test set requiring adjudication is described.

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 is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI-related comparative effectiveness is mentioned or relevant here.

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

Not Applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no "standalone algorithm" performance assessed in this context.

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

Not Applicable. There is no mention of ground truth in the context of validating a diagnostic algorithm's performance. The "ground truth" for this submission is effectively the established safety and effectiveness of the identified predicate devices and compliance with regulatory standards.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not Applicable. As per point 8, there is no training set, and therefore no ground truth establishment for a training set.

Summary

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K041499

(JUN 1 0 2004

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	PO Box 2068,2441 Michelle Drive Tustin, CA 92781-2068
Contact:	Paul Biggins, Sr. Manager of Regulatory Affairs
Telephone No.:	(714) 730-5000
Device Proprietary Name:	SSA-770A, APLIO Version 5.5
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:

1. Toshiba SSA-770A, Aplio Version 4.0 Diagnostic Ultrasound; 510(k) control number K032281
1. Siemens Medical Solutions Sequoia 8.0 Diagnostic Ultrasound System; 510(k) control number K032281

Device Description:

Intended Use:

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601 (applicable portions), IEC60601-2-37 (applicable portions), 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

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

Re: K041499

K041477
Trade Name: APLIO Diagnostic Ultrasound System, Model SSA-770A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 4, 2004 Received: June 7, 2004

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(K) prematerially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regars atment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the enability with the provisions of the Federal Food, Drug, and devices that nave been receasined in are reader we device, subject to the general controls Cosment Act (Act). Tou may, mercrors, in the Act include requirements for annual provisions of the Act. "The general vehiclering practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use I ins determination of savstanial oqur allers upposes in the many of the many of the many of notification:

Transducer Model Number

PST-25AT	PLT-1204AX	PST-37CT
PVT-375AT	PC-20M	PST-30BT
PVT-661VT	PET-510MB	PLT-704AT
PLT-805AT	PLT-1202S	PLT-1204A
PST-20CT	PET-704LA	PVT-375AX

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PST-65AT	PLT-308P	PVT-375BT
PLT-604AT	PET-508MA	PVT-382BT
PST-50AT	PVT-770RT

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) into elabor regulations affecting your device can be may be subject to such additions, Title 2, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register

furnier announcenting concerning your as not the the the the mination does not mean that Flease be advised mat 1 271 's issualled of a eveemonomies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all r cocration and regulations administed to: registration and listing (21 CFR Part 807); the Act s requirements, merading, but notacturing practice requirements as set forth in the quality labeling (21 CFR Part 007), good manazive; 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 The I DA midnig of substantial equivice 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 If you desire specific ad roo for your and additionally, for questions on the promotion comact the Office of Compines at (301) 594-4639 Compliance at (301) 594-4639. Also, and advertising of your deviles, prease vehicles by reference to premarket notification" (21 CFR picase note in regulation on the responsibilities under the Act may be obtained from I at 801:27). Other general Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David An. Lynn

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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System X_ Transducer____ SSA-770A______________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

								Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P
Intraoperative (Specify)**	P	P	P		P	P	P	P
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (Specify)***	P	P	P		P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac	P	P	P	P	P	P	P	P	P	E'	P	P
Transesophageal	P	P	P	P	P	P	P	P		E'		P
Transrectal	P	P	P		P	P	P	P	P
Transvaginal	P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P	P	P
Laparoscopic	P	P	P		P	P	P	P
Musculo-skeletal	P	P	P		P	P	P	P	P
Superficial
Musculo-skeletalConventional	P	P	P		P	P	P	P	P

entralia.
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Collanceral Conancils: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

E'-- Added via LTF against SSA-700A 510(k) control number K022400
Previous 510(k) for this device K013633
** Abdominal
*** For example: thyroid, parathyroid, breast, scrotum and penis

(P).EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamilah Begum

(Division Sign Division of Re and Radio 510(k) Numbe

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Transducer_X__ System __ PST-25AT_ Model_ 510(k) Number(s)

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic									P	E¹	P
Cardiac	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Continution ContinuedPWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

E' - Added via LTF against SSA-700A 510(k) control number K022400 Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEVEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Ch. Sayre

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devic 510(k) Number

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Transducer X System __ PVT-375AT Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	ાં રRSI	TDI-Q
Ophthalmic
Fetal	P	P	P		P	P	P	P	P
Abdominal	P	P	P		P	P	P	P	P
Intraoperative (Specify)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P	P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF;

Previous 510(k) for this device K013633

(PI.E.A.SE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seryson

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number _

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Transducer X System _______________________________________________________________________________________________________________________________________________________________________ PVT-661 VT Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P		P	P	P	P	P
Transvaginal	P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Auditional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Ingram

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Device 510(k) Number _

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Transducer X System _ PLT-805AT Model 510(k) Number(s)

								Mode of Operation
Clinical Application	B	M	P W D	C W D	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging	1.5 Harmonic	1.5 RSI	TDI- Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)	P	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletal	P	P	P		P	P	P	P	P
Superficial
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Commonts: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Ch. Johnson

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices : 10(k) Number _______________________________________________________________________________________________________________________________________________________________

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Transducer X System _ PST-20CT_____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEVBDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDEDI Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel k. Leyman

(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number

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Transducer_X System __ PLT-1204AX____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)	P	P	P		P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalSuperficial	P	P	P		P	P	P	P	P
Musculo-skeletalConventional	P	P	P		P	P	P	P	P

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Continents: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE / CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRII, Office of Device Eyaluation (ODE)

David A. Syverson

(Division Sign-Off) (Division of Reproductive, Abdo and Radiological Devices 51()(k) Number _______________________________________________________________________________________________________________________________________________________________

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Transducer X System __ PC-20M Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric				P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac				P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skelctal
Superficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by i DA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number __

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Transducer X System __ PET-510MB Model_ 510(k) Number(s)

Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac										E		P
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletalConventional

entonal
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Auditional Continents: - BDF/MDF/PWD:B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David M. Segeen

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number ___

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Transducer_X System __ PLT-1202S Model_ 510(k) Number(s)

Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)	P	P	P		P	P	P	P	P
Intraoperative Neurological
Pediatric
Small Organ (Specify)	P	P	P		P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHV2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Egerom

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number --

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

Transducer X System _ PET-704LA Model_

510(k) Number(s)

Clinical Application	B	M	P W D	Color Doppler	Color Velocity Imaging	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P	P	P	P
Musculo-skeletal
Superficial
Musculo-skeletal Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Continuer; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEFDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legerm

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic									E
Fetal	E	E	E	E	E	E	E	E	E
Abdominal	E	E	E	E	E	E	E	E	E
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

In cational
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:
Combined Modes:	B/M; B/PWD;
	BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
	CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Legron

(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Transducer X System _ PST-30BT Model_ 510(k) Number(s)

		Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal	E	E	E	E	E	E	E	E	E
Intraoperative(Specify)
IntraoperativeNeurological
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	E	E	E	E	E	E	E	E	E	E	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional
N= new indication; P = Previously Cleared by FDA;								E = Added under Appendix E (LTF)
Additional Comments: _______						Combined Modes: B/M; B/PWD;
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEWDED)

Avr.

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K041499

ﺴﻌﺪ ﺴﻌ

A-16

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

Transducer X System _ PLT-704AT____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)	E	E	E		E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E	E	E
Laparoscopic
Musculo-skeletalSuperficial	E	E	E		E	E	E	E	E
Musculo-skeletalConventional	E	E	E		E	E	E	E	E

N=new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Addidonal Comments: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(Please do not write below this line - continue on OTher Pages if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) (Ofvision Sign of Reproductive, Abdominal, and Radiological Devices 5 10(k) Number _______________________________________________________________________________________________________________________________________________________________

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

Transducer X System _ PLT-1204AT___________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s) .

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)	E	E	E		E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E	E	E
Laparoscopic
Musculo-skeletal	E	E	E		E	E	E	E	E
Superficial
Musculo-skeletalConventional	E	E	E		E	E	E	E	E

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Auditional Colliniedia: - BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(Please do not write below this line - continue on other pages if needlid) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniela Legmann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Transducer X System __ PVT-375AX____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal	E	E	E		E	E	E	E	E
Abdominal	E	E	E		E	E	E	E	E
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	E	E	E		E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Auditional Collinients:-------------------------------------------------------------------------------------------------------------------------------------------------------CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(Please do not write below this line - continue on Other Pages if Needbed) Concurrence of CDRH, Office of Device Evaluation (ODE)

David Le. Anderson

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number _

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic	E	E	E	E	E	E	E	E	E
Adult Cephalic
Cardiac	E	E	E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skelctalSuperficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Collinions: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRII, Office of Device Evaluation (ODE)

David Ch. Segen

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

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

and the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the seat of th

Transducer X System _______________________________________________________________________________________________________________________________________________________________________ PLT-604AT____________________________________________________________________________________________________________________________________________________________________ Model_ ______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)	E	E	E		E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E	E	E
Laparoscopic
Musculo-skeletal	E	E	E		E	E	E	E	E
Superficial									E
Musculo-skeletalConventional	E	E	E		E	E	E	E	E

Inventional
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Comments.
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF; FEVBDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)
CODED Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041499

{21}------------------------------------------------

Transducer_X System _ PST-50AT______________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic	E	E	E	E	E	E	E	E	E
Adult Cephalic									E	E		P
Cardiac	E	E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

nventonal
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:
Combined Modes:	B/M; B/PWD;
	BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
	CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEFDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Lyman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __

{22}------------------------------------------------

Transducer_X System __ PLT-308P_ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal	E	E	E		E	E	E	E	E
Intraoperative (Specify)	E	E	E		E	E	E	E	E
IntraoperativeNeurological
Pediatric	E	E	E		E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Adultional Continents: - BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEVBDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

{23}------------------------------------------------

Transducer_X System _ PET-508MA_____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac										E	E	E
Transesophageal	E	E	E	E	E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

emonal
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:	Combined Modes: B/M; B/PWD:
	BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;
CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEFDED)
CONVENTED OF CHANAK - OCT - - - F Decise Free Free West - CONVI Concurrence of CDRII, Office of Device Evaluation (ODE)

David R. Syverson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __

{24}------------------------------------------------

Transducer_X System __ PVT-770RT_____________________________________________________________________________________________________________________________________________________________________ Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	E	E	E		E	E	E	E	E
Transvaginal	E	E	E		E	E	E	E	E
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

N= new indication: P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Auditional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

(PLEASE DO NOT WRITE BFLOW THIS LINE - CONTINUE ON OTHER PAGES IF NEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. byrum

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{25}------------------------------------------------

Transducer X System __ Model_________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

		Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic
Fetal	E	E	E		E	E	E	E	E
Abdominal	E	E	E		E	E	E	E	E
Intraoperative (Specify)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletalConventional

N= new indication: P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Additional Comments: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEDEDED) E DONA MRTE DESON AND Office of Device Evaluation (ODE)

David be Sypm

(Division Sign-Off) Opision of Reproductive, Abdom and Pladiological Devices 5 Hopen Mumber _______________

{26}------------------------------------------------

Transducer X System _______________________________________________________________________________________________________________________________________________________________________ Model____ PVT-382BT__________________________________________________________________________________________________________________________________________________________ . ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5Harmonic	1.5RSI	TDI-Q
Ophthalmic									E
Fetal	E	E	E		E	E	E	E	E
Abdominal	E	E	E		E	E	E	E	E
Intraoperative (Specify)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: Adultional Comments: BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDEU)
THE CONSULTION COMMENT CATT - - F. Device Ecoluncion (ADDE) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerstrom

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.