APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

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

Device Description

The Aplio XG Ultrasound System is a mobile 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

The provided document is a 510(k) summary for the Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new algorithms or AI-driven devices.

The information provided primarily relates to the intended use and safety considerations based on existing standards, rather than the results of novel performance studies. The "acceptance criteria" discussed in the document are about the device's adherence to regulatory standards and its equivalence to predicate devices, not specific performance metrics in a clinical study.

Therefore, many of the requested items (e.g., specific acceptance criteria values, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) cannot be extracted from this document as it does not describe such a study.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of this 510(k) (substantial equivalence to predicate devices), the "acceptance criteria" are implied to be the safety and performance characteristics of the predicate devices. The "reported device performance" is that the new device is substantially equivalent to these predicates.

The document lists various transducers and the clinical applications they are cleared for, along with the available operating modes. "P" indicates "Previously Cleared by FDA" (implying equivalence to previous versions/predicate devices) and "E" indicates "Added under Appendix E (LTF)", meaning these indications were already covered by the previous 510(k) for that specific transducer model. "N" indicates "new indication" for the specific transducer and mode combination.

Since this document is a 510(k) summary for an ultrasound system, the acceptance criteria are generally based on meeting the performance and safety standards of the predicate devices and applicable industry standards. There are no quantitative performance metrics (e.g., sensitivity, specificity for disease detection) for a specific clinical task mentioned in this document that would be applicable for the requested table format.

The "performance" is demonstrated by its substantial equivalence to the following predicate devices:

Toshiba SSA-790A, Aplio XG Version 1.00 Diagnostic Ultrasound; 510(k) control number K063130
Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System; 510(k) control number K052410

The device (Aplio XG Version 2.00) meets the acceptance criteria by being demonstrated as substantially equivalent to these predicate devices for the listed clinical applications and operating modes. Specific performance characteristics for images for each clinical indication (e.g., image resolution, penetration depth, contrast) are usually detailed in the full 510(k) submission, not typically summarized quantitatively in the publicly available summary letter like this one.

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) summary establishing substantial equivalence to predicate devices and adherence to consensus standards. It does not describe a clinical performance study with a test set of patient data to evaluate a new algorithm or AI device.

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. This document does not describe a study involving expert-established ground truth for a test set.

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

Not applicable. This document does not describe a study involving ground truth adjudication.

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 document does not describe an MRMC study. It is a 510(k) for a diagnostic ultrasound system, not an AI-assisted interpretation device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. This document does not describe a study with a ground truth dataset in the context of diagnostic accuracy. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

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

Not applicable. This document does not describe the development or testing of an AI algorithm requiring a training set.

Summary

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K072000

510(k) Summarv 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, Director Regulatory Affairs
Telephone No.:	(714) 730-5000
Device Proprietary Name:	SSA-790A, Aplio XG Version 2.00
Common Name:	Diagnostic Ultrasound System
	JUL 30 2001
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-790A, Aplio XG Version 1.00 Diagnostic Ultrasound; 510(k) control number K063130
1. Siemens Medical Solutions U.S.A. Acuson Sequoia Ultrasound System;510(k) control number K052410

Device Description:

Intended Use:

Safety Considerations:

This device is designed and manufactured in conjunction with the Ouality System Regulation. IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), 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 consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle, with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 U 2007

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

Re: K072000

Trade Name: Aplio XG Diagnostic Ultrasound System, Model SSA-790A version 2.0 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 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 20, 2007 Received: July 23, 2007

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 Aplio XG Diagnostic Ultrasound System, Model SSA-790A version 2.0, as described in your premarket notification:

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Transducer Model Number

PVT-375BT	PLT-805AT	PST-50AT
PVT661VT	PLT-1204AT	PST-65AT
PLT-1202S	PLT-1204AX	PLT-704SBT
PC-20M	PVT-382BT	PLT-1204MV
PET-510MB	PVT-674BT	PVT-382MV
PST-25BT	PVT-575MV	PVT-681MV
PLT-604AT	PVT-770RT	PET-511BTM
PLT-704AT	PST-30BT

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

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.

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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Vopul Nithay for NCB

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

Model SSA-790A 510(k) Number(s)

STO(K) Number(S)

Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	Combined(Specify)
Ophthalmic
Fetal	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		P
Small Organ (Specify)*	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	P	P
Transesophageal	P	P	P	P			P	P	P		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
Laparoscopic
Musculo-skeletalSuperficial	P	P	P	P	P			P			P
Musculo-skeletalConventional	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: 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

All indications were previously reported via K063130

: For example: thyroid, parathyroid, breast, scrotum and penis

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

Prescription Use (Per 21 CFR 801.109)11

Jwhay

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

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System _ Transducer X Model___PVT-375BT 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P		P				P
Abdominal	P	P	P	P	P	P		P				P
Intraoperative (Specify)
IntraoperativeNeurological
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K063130

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

twhen

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

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

Clinical Application	Mode of Operation
	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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-skeletalSuperficial
Musculo-skeletalConventional

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K063130

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

JWhang

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

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and the control control control control control of the control of

Transducer X System PLT-1202S Model 510(k) Number(s)

JTD(x) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)	P	P	P	P	P			P				P
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*	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
Laparoscopic
Musculo-skeletalSuperficial	P	P	P	P	P			P				P
Musculo-skeletalConventional	P	P	P	P	P			P				P

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

Previous 510(k) for this device K063130

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

TWh

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

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Transducer_X System PC-20M Model

510(k) Number(s)

Mode of Operation

Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric									P
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac									P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular									P
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletalConventional

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

Previous 510(k) for this device K063130

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JWhay

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

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

						Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P			P	P	P			P
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)

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

Previous 510{k) for this device K063130

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

Thhang

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

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Transducer _ X System PST-25BT Model 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	P			P
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	P	P			P
Small Organ (Specify)*
Neonatal Cephalic	P	P	P	P	P	P	P	P	P			P
Adult Cephalic	P	P	P	P	P	P	P	P	P			P
Cardiac	P	P	P	P	P	P	P	P	P			P
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)

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

Previous 510(k) for this device K063130

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

JWhay
(Division Sign-Off)

(Division of Reproductive, Abdomin Radiological Devices 510(k) Number

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Transducer X System -PLT-604AT Model 510(k) Number(s)

e, 0 (π), π, ππ/6, π/4

	Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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)
Additional Comments: Combined Modes: B/M; B/PWD;
BDF/PWD; BDF/MDF; BDF/MDF/PWDPrevious 510(k) for this device K063130

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

Jhway

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

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Transducer _X System Model PLT-704AT

510(k) Number(s)

						Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Thhay

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

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

Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	PW
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

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

Dhang

(Division Sign-Off)

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

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and the contraction of the comments of the country of the country of the country of

System Transducer X

PLT-1204AT Model

510(k) Number(s)

				Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K012000

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Transducer X System

PLT-1204AX Model

510(k) Number(s)

Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
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 Superficial	E	E	E	E	E	E		E					E
Musculo-skeletal Conventional	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: BDF/PWD; BDF/MDF; BDF/MDF/PWD and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the first of t

Prescription Use (Per 21 CFR 801.109)

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

Thly
(Division Sign-Off)

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

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Transducer X System -PVT-382BT_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s) . .

の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000000000000000000000000000000000000000000000000000000

						Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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-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

DWh

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

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Transducer X System PVT-674BT Model

510(k) Number(s)

Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal	E	E	E	E	E	E		E				E
Abdominal	E	E	E	E	E	E		E				E
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Prescription Use (Per 21 CFR 801.109)

JWh

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

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Transducer X System Model PVT-575MV 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic	E	E	E	E	E	E		E				E
Fetal	E	E	E	E	E
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD ================================================================================================================================================

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

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System Transducer X

PVT-770RT Model 510(k) Number(s)

						Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
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
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletal
Conventional

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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Per 21 CFR 801.109)

and the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contri

JWhang

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072000

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Transducer X System

Model PST-30BT

510(k) Number(s)

		Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal	E	E	E	E	E	E	E	E	E			E
Intraoperative (Specify)
IntraoperativeNeurological	1
Pediatric	E	E	E	E	E	E	E	E	E			E
Small Organ (Specify)*
Neonatal Cephalic	E	E	E	E	E	E	E	E	E			E
Adult Cephalic	E	E	E	E	E	E	E	E	E			E
Cardiac	E	E	E	E	E	E	E	E	E			E
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/RWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

Thhang

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

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Transducer X System Model PST-50AT 510(k) Number(s)

		Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	E	E	E	E			E	E	E			E
Small Organ (Specify)*
Neonatal Cephalic	E	E	E	E			E	E	E			E
Adult Cephalic
Cardiac	E	E	E	E			E	E	E			E
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;

JWhly
(Division Sign-Off)

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

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Transducer X System PST-65AT Model

510(k) Number(s)

		Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	E	E	E	E			E	E	E			E
Small Organ (Specify)*
Neonatal Cephalic	E	E	E	E			E	E	E			E
Adult Cephalic
Cardiac	E	E	E	E			E	E	E	E		E
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)

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

JWhay

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

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

Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	PW	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletal	N	N	N	N	N	N	N	N
Superficial
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N

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

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

Thang

ivision Sian-Off ivision of Reproductive, Abdominal a Radiological Devices 510(k) Number

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Transducer _X System PLT-1204MV = = = Model 510(k) Number(s)

Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*	N	N	N	N	N	N		N					N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N		N					N
Laparoscopic
Musculo-skeletalSuperficial	N	N	N	N	N	N		N					N
Musculo-skeletalConventional	N	N	N	N	N	N		N					N

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

$\checkmark$Prescription Use (Per 21 CFR 801.109)

JWhay

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

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Transducer X System __ PVT-382MV_____________________________________________________________________________________________________________________________________________________________________ Model 510(k) Number(s)

						Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal	N	N	N	N	N	N		N				N
Abdominal	N	N	N	N	N	N		N				N
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric	N	N	N	N	N	N		N				N
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)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

TWhay
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(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

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Transducer X System ___ Model PVT-681MV 510(k) Number(s)

		Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	N	N	N	N	N	N		N					N
Transvaginal	N	N	N	N	N	N		N					N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
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

JWhers

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

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Transducer _X System PET-211BTM Model 510(k) Number(s) .

Clinical Application	B	THI	M	ColorDoppler	TDI	PW	CW	Combined(Specify)

Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	N	N	N	N	N	N	N	N
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Jwhen

(Division Sign-Off) Division of Reproductive, Abdominal 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.