The Aplio XG is intended to be used for the following types 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

The provided text is a 510(k) summary for a Toshiba Aplio XG Version 3.0 Diagnostic Ultrasound System. This document is a regulatory submission for medical devices and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner you might find for a novel AI/CADe device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided document. The document primarily lists the intended uses for various transducers and indicates whether these uses were "Previously Cleared by FDA" (P) or are "N= new indication." There is no section detailing performance metrics or studies to prove the device meets specific acceptance criteria.

The acceptance of this device for market clearance is based on its substantial equivalence to previously cleared predicate devices, specifically the Toshiba SSA-790A, Aplio XG Version 2.2, and the Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner. The "study that proves the device meets the acceptance criteria" in this context is the comparison to these predicate devices as detailed in the 510(k) submission, confirming that the new device does not raise new questions of safety or effectiveness.

Here's an attempt to structure what can be extracted from the provided text, while noting the significant lack of the detailed study information you requested:

Acceptance Criteria and Study for Toshiba SSA-790A, Aplio XG Version 3.0 Diagnostic Ultrasound System

Based on the provided 510(k) Summary, the acceptance criteria and study detailed below are primarily focused on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against a defined acceptance threshold for a novel AI/CADe functionality. The document does not contain the detailed clinical study information typically associated with proving performance characteristics of an AI/CADe device (e.g., sensitivity, specificity, reader performance improvements, sample sizes of test sets, expert qualifications, or adjudication methods).

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for performance metrics (like sensitivity or specificity) are not provided in this 510(k) summary (which is typical for ultrasound systems establishing equivalence rather than new AI/CADe performance), this table represents the intended uses and the status of those indications (new vs. previously cleared), which is the primary "performance" aspect evaluated for this type of submission.

Clinical Application (Example Transducer PST-30BT)	Acceptance Criteria (Implied: Substantially Equivalent or Previously Cleared)	Reported Device Performance (Status)
Fetal	Substantially Equivalent / Previously Cleared	P (Previously Cleared by FDA)
Abdominal	Substantially Equivalent / Previously Cleared	P
Pediatric	Substantially Equivalent / Previously Cleared	P
Neonatal Cephalic	Substantially Equivalent / Previously Cleared	P
Adult Cephalic	Substantially Equivalent / Previously Cleared	P
Cardiac	Substantially Equivalent / Previously Cleared	P
Various other applications across transducers	Substantially Equivalent / Previously Cleared / New Indication (but within historical performance)	P or N as indicated in forms

Note: The "acceptance criteria" here are implied by the 510(k) process itself, which requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the confirmation that the device's capabilities align with previously cleared indications or new indications that do not raise new questions of safety or effectiveness. For new indications (marked 'N'), the submission would typically provide justification, but this level of detail is not in the provided summary.

2. Sample size used for the test set and the data provenance:

Not provided. The document does not describe specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. Its focus is on the device's technical specifications and intended uses in comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. There is no mention of ground truth establishment, expert reviews, or qualifications in the context of a performance study.

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

Not provided. This information is not relevant to the type of 510(k) submission presented, which does not detail a clinical performance study with adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable / Not provided. This document precedes common AI/CADe applications in ultrasound systems and does not describe an MRMC study comparing human reader performance with and without AI assistance. The device is a diagnostic ultrasound system, not an AI or CADe device.

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

Not applicable / Not provided. The device is an ultrasound system, not an algorithm being evaluated in a standalone capacity.

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

Not provided. As no specific performance study with ground truth is detailed, this information is absent. For an ultrasound system like this, the "ground truth" for demonstrating equivalence would typically involve engineering and bench testing, comparison to predicate device specifications, and possibly clinical validation of image quality and diagnostic capabilities, but not in the sense of a definitive diagnostic ground truth for an AI algorithm.

8. The sample size for the training set:

Not applicable / Not provided. This device is a diagnostic ultrasound system, not an AI model, so there is no mention of a training set for an algorithm.

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

Not applicable / Not provided. As there is no AI model or training set discussed, this information is not present.

In summary, the provided 510(k) document is a regulatory filing for a diagnostic ultrasound system (Toshiba SSA-790A, Aplio XG Version 3.0), focusing on demonstrating substantial equivalence to predicate devices based on its intended uses and technical specifications. It does not contain the detailed clinical study performance data or AI/CADe-specific information that your questions are designed to elicit.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92 1. And 1

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 3.0 Common Name: Diagnostic Ultrasound System

AUG 1 2 2008

Classification:

Regulatory Class: II Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System Product Code: 90-IYN [Fed. Reg. No.: . 892.15501
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 2.2 Diagnostic Ultrasound; 510(k) K081065
1. Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner 510(k) K063518

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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three human figures underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9-2008

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

Re: K082119

Trade/Device Name: Aplio XG v3.0 SSA-790A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 26, 2008 Received: July 28, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of August 12, 2008.

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 v3.0 SSA-790A, as described in your premarket notification:

Transducer Model Number

PVT-375BT	PET-510MB
PVT-661VT	PST-25BT
PLT-1202S	PLT-604AT
PC-20M	PLT-704AT

{2}------------------------------------------------

PLT-805AT	PLT-1204MV
PLT-1204AT	PVT-382MV
PLT-1204AX	PVT-681MV
PVT-382BT	PET-511BTM
PVT-674BT	PC-50M
PVT-575MV	PLT-705BTF
PVT-770RT	PLT-705BTH
PST-30BT	PLT-1204BT
PST-50AT	PLT-1204BX
PST-65AT	PVT-745BTV
PLT-704SBT

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:

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

{3}------------------------------------------------

Page 2 - Mr. Job

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,

Logu Mkhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

Diagnostic Ultrasound Indic Thous For Use Form

System Transducer

Model & PVT-575MVAN Comments www.manage.com a

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

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

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

Previous 510(k) for this device K081065

(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)

Evaluation (ODE)

Hebert Lewin

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

መጨረሻ መጨረሻ የሚያስተዋል። መልክ አይነት የመጣለት የሚያስተዋል። በማምጣት ነው። የ

{5}------------------------------------------------

Diagnostic Ultrasound Indications For

Transducer

Model PVT-770RT

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
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 K081065

(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)

Hulutten
Division Sign-Off

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

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

Diagnostic Ultrasound Indications For Use Forn

ను. ప్ర కాస్ట్

్రామ్మ

Transducer X Model + PST-30BT =============================================================================================================================================================

510(k) Number(s)

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

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; FEVBDF

Previous S10{k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

(Division Sidn-Off Division of Reproductive, Abdominal and Radiological Devi 510(k) Number

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

Djagnostic Ultrasonia mara tijon 1 marta 1 to an

er (){ var legge कि है ్లో చ System Transducer X

System PST-50AT --------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number(s)

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

(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 Sigh-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

. Diagnostic Ultrasound Indications For Use Form .

1889

Fransducer X

Feller PST-65AThe ------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

1. 1. 1. 1. 2

18:578 : 1

	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)

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; FEVBDF

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

iagnostic Ultrasound Indications Tor I

ransducer

Model -- PLT-704SBT

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)

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

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

. Diagnosne Ultrasound Indications For Use Edrin

ransdillo 204MV

e - - - - - - - - - - - - - - - - - - - - -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				P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethra!
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P				P
Laparoscopic
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P				P
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

Previous 510(k) for this device K081065

(PLEASE DO NOT WRITE BEL

SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
---------------------

Prescription Use (Per 21 CFR 801.109)

(Uivision Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K682119 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

. Diagnostic Ultrasound Indication with art 10 - 1

ું પ્રતુ

, A - 1 - 7 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 的影院

STORES OF THE SEAR THE COLLECT TO THE COLLECT TO COLLECT TO COLLECT TO COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECT

Transducer stem Model -- PVT-382MV ---------------------------------------------------------------------------------------------------

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)

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

Previous 510(k) for this device K0810650

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NE 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}------------------------------------------------

Diagnostic Ultrasound Indications For Use Form .

Model PVT-681MV

ransdi

510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
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-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 K081065

(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}------------------------------------------------

Diagnostic Ultrasound Indications Cor Use Form

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
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)

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

(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	15082119

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

Diagnostic Uli sound l ੍ਹਾ ਗਿ

System "Tra

Model PC-50M

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-skeletalSuperficial
Musculo-skeletalConventional

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

Additional Comments:

Previous 510(k) for this device K081065

(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 ા તા 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Diagnostic Ultrasound Indications For Use Form

Transducer X System PLT-705BTF 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	N	N	N	N	N	N		N				N
Intraoperative (Specify)	N	N	N	N	N	N		N				N
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
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

(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 K082119

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

Diagnostic Ultrasound Indications For Use Form

Transducer _X System _ PLT-705BTH Model 510(k) Number(s)

Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	PW	Combined (Specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	N
Intraoperative (Specify)	N	N	N	N	N	N	N	N
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
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments:
BDF/PWD; BDF/MDF; BDF/MDF/PWD
Combined Modes: B/M; B/PWD;Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

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

iagnostic Ultrasound Indications For Use Form

ות מאי

State State of the markets of the state and the

. . P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12:27:54

ransducer X min - 1 1 % to em 204B Model

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number(s)

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QD) (Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Reproductive, Abdomina

Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications For Use Form

System X Transducer Aplio XG v3.0 SSA-790A_ Model 510(k) Number(s)

Carlos Concession Consideration of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chil

		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			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	N	N	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	N	N	P	P			P
Laparoscopic
Musculo-skeletalSuperficial	P	P	P	P	P	N	N	P				P
Musculo-skeletalConventional	P	P	P	P	P	N	N	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/RWD: BDF/MDE: BDF/MDE/PWD:B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D: FEI/2D: CHI/BDF: FEVBDF

All indications were previously reported via K081065

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

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

Prescription Use (Per 21 CFR 801.109)11

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 12082114 510(k) Number

A-4

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

े में में में में में मिले में में प्रशासन में मिल सुरुवा बाद मिल रहे हैं कि र
िक में बाद में बाद में ही गुजावन में किसी में प्रकार किया था। बाह प्रकार किस स
े बाद में बाद म

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

నిరా

Transduce PVT-375BT 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)
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-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 K081065

(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)

Helson

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

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

iagnosita l'Ion Folind Indica TOTIC

1954

.. ﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ

Model PVT-66IVT

Model 1-FOOT V
5100's Number(s)

510(k) Number(s)

发

	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	P	P	P	P	P	P		P				P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal Conventional

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

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

Previous 510(k) for this device K081065

(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 4082119 510(k) Number _

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

. Co., Diagnostic Ultrasound Infolla (mir ann ann an Sans

Start of Transducer Sos

PLT-1202S Model

510(k) Number(s)

and the comments of the comments of the comments of the comments of the comments of the first of the first of the first of the first of the first of the first of the first of

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

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

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

Helena Sommer

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 11-08211 510(k) Number -

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

nostic 1014, com of the more of

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

nsdi Model PC-20M

510(k) Number(s)

1 4 4 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

1.17.20

	Mode of Operation
Clinical Application	8	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-skeletal
Superficial
Musculo-skeletalConventional

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

Additional Comments:

Previous 510(k) for this device K081065

(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)

Vell Lence

(Division Sign-Off)

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

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

Diagnostacaging and the China China (Italia ya Post
a

الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو

2:21 80.000

ינק יוני עינו

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-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 K081065

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

Prescription Use (Per 21 CFR 801.109)

Haddad Limmen

... ... ... ..

2.01.6222

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 1082119 510(k) Number

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

में स्वास्थ्य में स्वागति में प्रतीय साल में कि महिला है। शुरू किया

ાં ડાંગ

1991 11:49

. I

Fransduce Model_PST-25BT

510(k) Number(s)

,一

	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	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TD1; 2D/CWD; BDF/CWD; CHI/2D; FEV2D; CHI/BDF; FEI/BDF; FEI/BDF

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

Hh. Rem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K082119 510(k) Number __

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

Diagnostica di tra Komita bitlio Tihak di majin (li

1999 - 1999

人的 ાં

A .. Both Combines St.

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

Transducer X and

રિક ન

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 K081065

(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 Sign-Off) Division of Reproductive, Abdominal and Radiological Devices NO82119 510(k) Number _

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

وال سال المقال بين صورت الوالي الصحي الروالي الصحي التي في ال

: 上一篇:

1003 1295

19:12:43 19:54

ansducer and the ,在此

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) *	P	P	P	P	P	P	P						P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P		P					P
Laparoscopic
Musculo-skeletal	P	P	P	P	P	P		P					P
Superficial
Musculo-skeletal Conventional	P	P	P	P	P	P		P					P

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

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

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

signature

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

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

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Model PL L-805AT - 805AT 11 - 1944 12 2017 11:54 ్రాలు . የራ 510(k) Number(s)

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						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: _________________________________________________________________________________________________________________________________________________________ BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previous 510(k) for this device K081065

(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 _

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

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Model -- PLT-1204AT
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 K081065

(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)

Evaluation (SDE)

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

{29}------------------------------------------------

্রামের মাধ্যমে মানুষ মানুষ মানুষ মানুষ প্রতিষ্ঠান করে বিশ্বকাপে পারে।

প্রতিষ্ঠান
প্রকল্পিত বিশ্বকাপ ្រ

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510(k) Number(s)

4 35 44

						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				P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P		P				P
Laparoscopic
Musculo-skeletalSuperficial	P	P	P	P	P	P		P				P
Musculo-skeletalConventional	P	P	P	P	P	P		P				P

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

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

Previous 510(k) for this device K081065

(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)

Helentame

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

{30}------------------------------------------------

ហាន់ខ្លាំងទៅរបស់ក្រុងព្រៃជាជាគ្រប់ទេ មានក្រុមនោះ នេះក្រោះ អនុរ 的

13 - 201

2.5 (2) 2

System - - - Transducer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Model : PVT-382BT

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 K081065

(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)

e Evaluation (ODE)

(Division Sign-Off)

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

{31}------------------------------------------------

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Model PVT-674BT-- States of the

510(k) Number(s)

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

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

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

Previous 510(k) for this device K081065

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

Prescription Use (Per 21 CFR 801.109)

luation (ODE)

(Division Sign-Off)

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

A-17

{32}------------------------------------------------

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िली के मुख्यमंत्री में स्वास्त्री के लिए सितंबर बिहार स्टेशन के बाद हो गया
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* System - Transdueds X - Transducer - Same - System

Model PLT-1204BX Model > PLT-1204BX > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

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		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				N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N				N
Laparoscopic
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N				N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N				N

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

(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)

Helin Sume

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082119

{33}------------------------------------------------

ে প্রকাশন ও পরিবার প্রধানমন্ত্রী করে না করে বাস্তার করে বাস্তারী ও

,在一起的 . System Ministration of the mail of the state of the mail of the comments of the comments of the comments of the counter

S i 0(x) Number(s)

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

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

Prescription Use (Per 21 CFR 801.109)

Helstema
(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.