SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

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. This submission is to clear cardiac packages already in place on predicate devices.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Toshiba SSA-770A, APLIO Version 4 Diagnostic Ultrasound System. It details the device's technical specifications, intended uses, and its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding acceptance criteria or a specific study that proves the device meets such criteria. The document focuses on regulatory clearance by demonstrating substantial equivalence to existing devices, and lists various transducers with their cleared modes of operation and clinical applications. There are no performance metrics, accuracy statistics, or study designs mentioned that would typically be associated with proving a device meets specific acceptance criteria based on quantifiable performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study evaluating its performance against such criteria. The document primarily functions as a regulatory submission detailing the device's characteristics and intended use, rather than a performance evaluation report.

Summary

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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
Facsimile No .:	(714) 730-1310

Device Proprietary Name:	SSA-770A, APLIO Version 4
Common Name:	Diagnostic Ultrasound System

Classification:

Regulatory Class:	II
Review Category:	Tier II
Panel:	Radiology

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 Diagnostic Ultrasound; 510(k) control number K013633
1. Toshiba SSA-700A, AplioSL Diagnostic Ultrasound; 510(k) control number K022400
1. Acuson Sequoia Signature II Diagnostic Ultrasound; 510(k) control number K022567
1. GE Vingmed Ultrasound System FiVe, 510(k) control number K991842.

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

AUG - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Ms. Laura Danielson Responsible Third Party TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K032281

Trade Name: SSA-770A - Version 4, APLIO Diagnostic Ultrasound System 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: 90 IYN, IYO, and ITX Dated: July 23, 2003 Received: July 24, 2003

Dear Ms. Danielson:

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 SSA-770A - Version 4, APLIO Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PST-25AT PVT-375AT

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PVT-661VT PLT-805AT PST-20CT PLT-1204AX PC-20M PET-510MB PLT-1202S PET-704LA PST-37CT PST-30BT PLT-704AT PLT-1204AT PVT-375AX PST-65AT PLT-604AT PST-50AT PLT-308P

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:

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Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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 A. Lygram

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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Transducer System X

Model SSA-770A 510(k) Number(s)

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	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	P	P
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (Specify)***	P	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	E1	N	N
Transesophageal	P	P	P	P	P	P	P	P	P	E1		N
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Laparoscopic	P	P	P	P	P	P	P	P
Musculo-skeletal	P	P	P	P	P	P	P	P	P
Superficial
Musculo-skeletalConventional	P	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/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

E 1 – 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

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

DAS
Division Sign-Off

and Radiological De 510(k) Number

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Transducer X System Model PST-25AT 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	P	P	P	P	P	P	P	P	P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	E 1		N
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

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

Daniel A. Seymour

(Division Sign-O Divisio and Radiological D 510(k) Numbe

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

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	1.5THI	1.5RSI	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-skeletal
Conventional

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

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. Segerson

(Division Sign-Off) Division of Reproduct and Radiological Devic 510(k) Number

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

Transducer X System PVT-661VT 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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P		P	P	P	P	P
Transvaginal	B	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)

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; 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. Ingram

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

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

Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	1.5RSI	TDI-Q
Clinical Application
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
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/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

*** For example: thyroid, parathyroid, breast, scrotum and penis Previous 510(k) for this device K013633

David A. Serson

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

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	1.5THI	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	P	P	P	P	P	P	P	P	P
Cardiac	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)

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

Previous 510(k) for this device K013633

(PLEASE DO NOT WRITE BELOW THIS ( DNE - CONTINUE ON OTHER I Concurrence of CDRH, Office of Device Evaluation (C

David A. Seymann

Divisi and R 510(k) Numb

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

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

	Mode of Operation
Clinical Application	B	M	P	C	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging	1.5 THI	1.5 RSI	TDI-Q
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
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: 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

*** 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)

David A. Hyman

(Division Sian-Off Division of Renmolue and Radiological De 510(k) Numbe

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

Transducer X System Model PC-20M 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				P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac				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

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 A. Hagman

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

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

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging	1.5THI	TDI-Q
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	P	E¹	N
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

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

David A. Lyman

of Reproductive 510k) Numb

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

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	1.5THI	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-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/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

Previous 510(k) for this device K013633 *** For example: thyroid, parathyroid, breast, scrotum and penis

David R. Segerson

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

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

Transducer X System PET-704LA Model 510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging	1.5 THI	1.5 RSI	TDI-Q
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	P
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; 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 A. Szyman

(Division Sign-Off Division of Reproductive. Abd and Radiological Devic 510(k) Number

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

System Transducer X PST-37CT 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	E
Abdominal	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

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

David A. Seymour

(Division Sign-Off) Division of Reproductive. and Rac 510(k) Numb

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

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
Intraoperative(Specify)
Intraoperative
Neurological
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	N	N
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: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF;

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

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)
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-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: 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

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

David R. Ingram

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

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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)
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-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: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

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

David A. Lipton

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

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Transducer _X System _ PVT-375AX Model 510(k) Number(s)

Clinical Application	B	M	P W D	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging
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-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; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

Daniel A. Ingram

(Division Sign-O Division of Reproducti and Radiological De 510(k) Numbe

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Transducer _X System PST-65AT 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	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-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;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF

David A. Seymore

(Division Sign-O Divis Reproduct and 510(k) Num

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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)
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	E	E	E		E	E	E	E	E
Superficial
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;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

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

David h. Segarra

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

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

Transducer X System Model PST-50AT 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	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		N
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; FEI/2D; CHI/BDF; FEI/BDF

David A. Bergman

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

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System Transducer X PLT-308P Model 510(k) Number(s)

					Mode of Operation
Clinical Application	B	M	P W D	C W D	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)	E	E	E	E	E	E	E	E	E
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-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; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

Daniel A. Segner

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