Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML in medical imaging.

Therapeutic

No.
The device is described as a diagnostic ultrasound system intended for imaging various anatomical sites, which is for diagnosis, not therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" states the device is used for various "studies," which implies gathering information to aid in diagnosis. Furthermore, the predicate device explicitly mentions "Diagnostic Ultrasound," confirming its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile system" and employs "a wide array of probes," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Aplio XG Ultrasound System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use describes the system as being used for various in vivo (within the living body) ultrasound studies on different anatomical sites. IVD devices are used to examine specimens in vitro (outside the living body), such as blood, urine, or tissue samples.
Device Description: The description details a mobile ultrasound system with probes used for imaging within the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.

The Aplio XG is clearly a diagnostic imaging device used for visualizing internal structures of the body, which falls under a different regulatory category than IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Organs (e.g. thyroid, parathyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal (Superficial and Conventional).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K063130, K052410

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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:

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.

Intended Use:

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).

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.

1

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:

2

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.

3

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)

4

System X Transducer

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

STO(K) Number(S)

| 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 | | | P |
| Intraoperative (Specify) | P | P | P | P | P | | | P | | | | P |
| Intraoperative
Neurological | | | | | | | | | | | | |
| 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-skeletal
Superficial | P | P | P | P | P | | | P | | | | P |
| Musculo-skeletal
Conventional | 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

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Prescription Use (Per 21 CFR 801.109)11

Jwhay

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

i

5

System _ Transducer X Model___PVT-375BT 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	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)

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

Previous 510(k) for this device K063130

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twhen

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

6

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

Clinical Application	Mode of Operation
	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	P	P	P	P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

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

Previous 510(k) for this device K063130

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JWhang

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

7

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	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)	P	P	P	P	P	P	P
Intraoperative
Neurological
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-skeletal
Superficial	P	P	P	P	P	P	P
Musculo-skeletal
Conventional	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

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TWh

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

8

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)
Intraoperative
Neurological
Pediatric									P
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac									P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular									P
Laparoscopic
Musculo-skeletal
Superficial
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 K063130

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JWhay

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

9

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

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Thhang

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

10

Transducer _ X System PST-25BT 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	P	P	P	P	P	P	P	P	P	P
Intraoperative (Specify)
Intraoperative
Neurological
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-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 K063130

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JWhay
(Division Sign-Off)

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

11

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	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-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)
Additional Comments: Combined Modes: B/M; B/PWD;
BDF/PWD; BDF/MDF; BDF/MDF/PWDPrevious 510(k) for this device K063130

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Jhway

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

12

Transducer _X System Model PLT-704AT

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)

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

13

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)
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)

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

·

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Dhang

(Division Sign-Off)

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

14

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	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)

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

Prescription Use (Per 21 CFR 801.109)

Th

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

15

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
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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) . .

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	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal	E	E	E	E	E	E	E	E
Abdominal	E	E	E	E	E	E	E	E
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric	E	E	E	E	E	E	E	E
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-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

DWh

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17

Transducer X System 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	E	E	E	E	E	E	E	E
Abdominal	E	E	E	E	E	E	E	E
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

Prescription Use (Per 21 CFR 801.109)

JWh

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18

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 ================================================================================================================================================

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19

System Transducer X

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	E	E	E	E	E	E	E	E
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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

20

Transducer X System

Model PST-30BT

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	E	E	E	E	E	E	E	E	E	E
Intraoperative (Specify)
Intraoperative
Neurological	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-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; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

Thhang

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21

Transducer X System Model PST-50AT 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	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-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;

JWhly
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(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	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
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-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

JWhay

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23

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

24

Transducer _X System PLT-1204MV = = = 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)*	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
Superficial	N	N	N	N	N	N	N	N
Musculo-skeletal
Conventional	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

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25

Transducer X System __ PVT-382MV_____________________________________________________________________________________________________________________________________________________________________ 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	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intraoperative (Specify)
Intraoperative
Neurological
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-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

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

26

Transducer X System ___ Model PVT-681MV 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	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-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

JWhers

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27

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

| 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 | N | N | N | N | | | N | N | N | | | N |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | |

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