APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 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, adult 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. 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 the Toshiba Aplio XG SSA-790A (v2.2) Diagnostic Ultrasound System and its associated transducers. The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists the intended uses and safety considerations. It does not contain information typically found in acceptance criteria or a study proving that the device meets specific performance metrics in the way an AI/ML device submission would.

Therefore, I cannot extract acceptance criteria and a study that proves the device meets those criteria from the provided text in the manner requested for AI/ML performance.

Here's why and what information can be provided:

Device Type: This is a diagnostic ultrasound system, not an AI/ML device. For such medical imaging systems, FDA clearance typically relies on demonstrating safety and effectiveness based on established performance standards (e.g., electrical safety, acoustic output, image quality, and clinical functionality) rather than a statistically robust clinical performance study with specific acceptance criteria like accuracy, sensitivity, or specificity.
"Acceptance Criteria" in this context refers to regulatory compliance and equivalence, not clinical performance metrics for a specific algorithm. The "acceptance criteria" here are met by demonstrating that the device conforms to relevant industry standards and is substantially equivalent to a legally marketed predicate device.
"Study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process itself. The process of compiling and submitting the necessary documentation (including comparisons to predicate devices, engineering tests, and adherence to safety standards) is the "study" that proves regulatory acceptance.

Based on the provided text, here's what can be extracted, framed within the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance (Regulatory Equivalence / Compliance)

Acceptance Criterion (Implicit)	Reported Device Performance (from 510(k) Summary)
Substantial Equivalence to Predicate Devices	The device is believed to be substantially equivalent to: - Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000) - General Electric Co. VOLUSON E8 Ultrasound System (K061682)
Compliance with Regulatory Class II Requirements	Classified as II, Review Category: Tier II. Product Codes: 90-IYN, 90-IYO, 90-ITX.
Adherence to Safety Standards (General Controls)	Designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1, IEC 60601-1-2, IEC60601-2-37, AIUM-NEMA UD2, and AIUM-NEMA UD3.
Intended Use Statement Consistency	Intended for fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, and musculo-skeletal studies. This aligns with predicate devices (K072000) for all listed applications and transducer modes (as indicated by 'P' in the detailed tables).
Acoustic Output within Approved Levels (Post-Clearance)	A post-clearance special report is required containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G. (This is a condition for clearance, implying that meeting these levels is an acceptance criterion).

Note: Specific quantitative performance metrics (e.g., image resolution, penetration depth, frame rates) are typically part of internal design specifications and testing for traditional ultrasound devices but are not explicitly detailed as "acceptance criteria" in this FDA summary document, which focuses on regulatory clearance. The "performance" here is primarily about functional equivalence and safety.

Regarding the other requested information (which is more relevant for AI/ML studies):

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of images for algorithm performance evaluation. It's a regulatory submission for a hardware/software system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the same reason as above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a traditional device clearance, not an AI/ML effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system that is operated by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML evaluation. For an ultrasound system, "ground truth" would relate to the physical accuracy of its measurements and image rendering against known standards, and its safety.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary

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JUN - 6 2008

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, Director Regulatory Affairs
Telephone No.:	(714) 730-5000

	Device Proprietary Name: SSA-790A, Aplio XG Version 2.2
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-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000
1. General Electric Co. VOLUSON E8 Ultrasound System; 510(k) K061682

Device Description:

Intended Use:

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2008

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

Re: K081065

Trade/Device Name: Aplio XG SSA-790A (v2.2) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 19, 2008 Received: May 21, 2008

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 SSA-790A (v2.2), as described in your premarket notification:

Transducer Model Number

PVT-375BT PVT-661VT PLT-1202S PC-20M PET-510MB PST-25BT

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PLT-604AT
PLT-704AT
PLT-805AT
PLT-1204AT
PLT-1204AX
PVT-382BT
PVT-674BT
PVT-575MV
PVT-770RT
PST-30BT
PST-50AT
PST-65AT
PLT-704SBT
PLT-1204MV
PVT-382MV
PVT-681MV
PET-511BTM
PC-50M

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.

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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:

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 (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.

Arputh Whang

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 Aplio XG SSA-790A (v2.2) 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamic Flow	Combined(Specify)
Ophthalmic								P				P
Fetal	P	P	P	P	P	P		P				P
Abdominal	P	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			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												P
Intravascular
Peripheral Vascular	P	P	P	P	P	P		P	P			P
Laparoscopic												P
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; FEV2D; CHI/BDF; FEVBDF; FEVBDF

All indications were previously reported via K072000

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

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

(Division Sign-Off)

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

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System Transducer _X PVT-375BT 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	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-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

Previous 510(k) for this device K072000

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

hogar McWhay

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

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Transducer X System -Model PVT-661VT 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	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

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 K072000

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

Norval M. Ewing

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

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

Clinical Application	B	THI	M	ColorDoppler	Power	PW	Combined(Specify)
Mode of Operation
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

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 K072000

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

(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	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	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-skeletalSuperficial
Musculo-skeletal
Conventional

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

Additional Comments: _

Previous 510(k) for this device K072000

(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)

Aosaita Wh

(Division Division of Reproductive, Abdomina 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	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	P	P	P	P			P	P	P			P
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;

Previous 510(k) for this device K072000

(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)

(Division Sign-Off)

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

A-9

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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	CHI Dynamic Flow	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		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 K072000

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

Thomse M. Whay

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

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System Transducer X PLT-604AT_____________________________________________________________________________________________________________________________________________________________________ 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)*	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

Previous 510(k) for this device K072000

(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)

(Division Sign-Off)

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

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

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

TO(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)*	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

Previous 510(k) for this device K072000

(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)

.. ...

(Division Sign-Off)

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

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

Transducer _X System PLT-805AT 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)*	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

Previous $10(k) for this device K072000

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

Storm M. Weng
(Division Sign-Off)

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

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

Transducer X System 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)*	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

Previous 510(k) for this device K072000

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

Aogru M. Wher
(Division Sign-Off)

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

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System Transducer X PLT-1204AX 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)
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/PWD

Previous 510(k) for this device K072000

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

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

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

Transducer X System PVT-382BT 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	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 (LTE)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 K072000

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

(Division Sign-Off)

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

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

System . Transducer X PVT-674BT 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	P
	P
	P
	P
	P
	P
	P
	P
Abdominal	P
	P
	P
	P
	P
	P
	P
	P
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

Previous 510(k) for this device K072000

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

Prescription Use (Per 21 CFR 801.109)

. I

Amme In Whang
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __

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

and the comments of the comments of the comments of the comments of the contribution of the first of the first of the first of the first of the first of the first of the firs

Transducer X System PVT-575MV 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	P	P	P	P	P	P		P				P
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
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

Previous 510(k) for this device K072000

(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)

Aogui m Whz
(Division Sign-Off)

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

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

Transducer X System PVT-770RT 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)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P		P					P
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

Previous 510(k) for this device K072000

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

(Division Sign-Off)

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

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

System Transducer X PST-30BT 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		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 K072000

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

Aonald M. Weng

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

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

and the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contributio

Transducer X System PST-50AT 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	P	P	P	P			P	P	P			P
Small Organ (Specify)*
Neonatal Cephalic	P	P	P	P			P	P	P			P
Adult Cephalic
Cardiac	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)

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 K072000

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

(Division Sign-Off)

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

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

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	P	P	P	P			P	P	P			P
Small Organ (Specify)*
Neonatal Cephalic	P	P	P	P			P	P	P			P
Adult Cephalic
Cardiac	P	P	P	P			P	P	P			P
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

Previous 510(k) for this device K072000

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

(Division Sign-Off)

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

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

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

ﻣﺘﺤﺪﺛ

						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
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

under Appendix E (L

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

Previous 510(k) for this device K072000

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

Division Sign-Off

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

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

System_ Transducer _X Model

PLT-1204MV ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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)*	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

Previous 510(k) for this device K072000

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

(Division Sign-Off)

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

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

System Transducer X 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	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
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 K072000

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

Arzith Wrig
(Division Sign-Off)

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

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

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

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

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 K072000

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

Ayuu M. Why

(Division Sign-Off)

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

{27}------------------------------------------------

Transducer _X System PET-511BTM 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)
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/RWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

Previous 510(k) for this device K072000

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

(Division Sign-Off)

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

{28}------------------------------------------------

Transducer X

System _______________________________________________________________________________________________________________________________________________________________________ 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									N
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac									N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular									N
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Additional Comments:

)

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

Rogal Twth

(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.