The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vascular and urology exams.

Device Description

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System are general purpose, portable/mobile {with mobile ultrasound trolley}, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System. It focuses on demonstrating substantial equivalence to already-marketed predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information, particularly regarding detailed performance metrics, study design, and ground truth establishment, is not present in this document.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's functionality. Instead, it relies on demonstrating that the DP-20 and DP-30 systems are substantially equivalent to predicate devices (Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System (K102991), and M7 Diagnostic Ultrasound System (K103677)).

The "performance" described is in terms of general characteristics and adherence to safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
Acoustic Output	Conforms with applicable medical safety standards (UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1, IEC 62304)
Biocompatibility	Conforms with applicable medical safety standards
Cleaning and Disinfection Effectiveness	Conforms with applicable medical safety standards
Thermal Safety	Conforms with applicable medical safety standards
Electrical Safety	Conforms with applicable medical safety standards
Mechanical Safety	Conforms with applicable medical safety standards
Effectiveness/Functionality:
Ability to acquire and display ultrasound data in B-Mode, M-Mode, or combined B+M Mode	Functions as described (acquires and displays B-Mode, M-Mode, or combined B+M Mode data)
Intended Uses are comparable to predicate devices	Intended uses are consistent with traditional clinical practices, FDA guidelines, and established methods of patient examination. Broad range of applications (fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vascular, urology).
Technological Characteristics comparable to predicate devices	Has the same technological characteristics as predicate devices.
Key safety and effectiveness features comparable to predicate devices	Comparable in key safety and effectiveness features to predicate devices.
Basic operating modes comparable to predicate devices	Has the same basic operating modes as predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe any specific clinical or performance test set (dataset of cases) used to establish quantitative performance metrics. The demonstration of safety and effectiveness relies on adherence to established engineering and medical device standards, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients/images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a specific test set is mentioned, as the submission is not based on a clinical performance study with a new algorithm or diagnostic aid requiring such validation.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and subsequent adjudication method are described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an ultrasound imaging system, and the submission does not involve an AI algorithm or a comparative effectiveness study of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a standalone ultrasound imaging system, not an algorithm. Its "standalone" performance is assessed at the system level through adherence to safety and operational standards and comparison to predicate devices.

7. The Type of Ground Truth Used

Not applicable in the context of a new diagnostic algorithm. The "ground truth" implicitly referred to is the established safety and performance of predicate ultrasound systems and compliance with international and national safety standards.

8. The Sample Size for the Training Set

Not applicable. This document is for a medical device (ultrasound system), not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons mentioned above.

Summary

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

KII3/53

NOV 28 2011

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: K 1 1 153.

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5615 Fax: +86 755 2658 2680

Contact Person:

Tan Chuanbin Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: October 10th, 2011

2. Device Name:

DP-20 Digital Ultrasonic Diagnostic Imaging System (new added sub-model) DP-30 Digital Ultrasonic Diagnostic Imaging System (new added sub-model)

Classification

Regulatory Class: II 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

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

M-Mode, or their combined mode B+M Mode. The systems are Track 1 device that employs an array of transducers including linear array and convex array. The frequency range of DP-20 is approximately 2.0 MHz to 10.0 MHz and that of DP-30 is approximately 2.0 MHz to 12.0 MHz.

4. Intended Use:

5. Comparison with Predicate Device:

DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is comparable with and substantially equivalent to the Mindray DP-6900 Digital Ultrasonic Diagnostic Imaging System (K090912), M5 Diagnostic Ultrasound System(K102991) and M7 Diagnostic Ultrasound System(K103677). They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

6. Non-clinical Tests:

DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, ISO 10993-1 and IEC 62304.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent with respect to safety and effectiveness to devices

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

Image /page/2/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 image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

DEC -6 2011

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants. Inc. 55 Northern Blvd, Suite 200 GREAT NECK NY 11021

Re: K113153

Trade/Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: October 10, 2011 Received: October 25, 2011

Dear Ms. Goldstein-Falk:

This letter corrects our substantially equivalent letter of November 28, 2011.

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 DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:

Transducer Model Number

35C20EA	65EC10EB	75L53EA
35C50EB	65EL60EA	75LT38EA
65C15EA	75L38EB	35C20EA

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

35C50EA65C15EA65EC10EA65EL60EA	65EB10EA65EC10ED75L38EA75L53EA	75LT38EA10L24EA
--------------------------------------------	--------------------------------------------	---------------------

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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.

Sincerely yours.

Michael D. O'Hare for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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

NOV. 29. 2011 3:13PM

Indications for Use

: 510(k) Number (if known):
Device Name: DP-20, DP-30 Digital Ultrasonic Diagnostic Imaging System

Indications for Use:

The DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology.

AND/OR Over - The - Counter Use Prescription Use X (21 CFR Part 801 Subpart D) (21 CFR Part B07 Support C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (O(VD)

Ar. A. ADDI

Office of the Vitty Disc man was was and Ba

sick 15/13/53

0029

-ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

1 - 1

Sussan D. Galdeterin-Falk

BABSCOPED DO TH FAX FAX 999925544

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

NOV. 29. 2011 3:13PM

್ಕ

Diagnostic Uttrasound Indications for Use Form Transdiscer x |

System Modol: 510(k) Number(a)

DP-20 KITSTED

Clinical Application	B	M	Combined (specify)	Other (specify)
Ophthalmic
Fetal	N	N	N	Note 1, Note2
Abdominal	N	N	N	Note 1, Note2
Intraoperative (specify)*	N	N	N	Note 2
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	Note 1, Note 2
Small organ (specify)**	N	N	N	Note 2
Neonatal Cephalic	N	N	N	Note 2
Adult Cephalic	N	N	N	Note 2
Trans-rectal	N	N	N	Note 2
Trans-vaginal	N	N	N	Note 2
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	N	N	N	Note 1, Note 2
Musculo-skeletal Superficial	N	N	N	Note 2
Intravascular
Cardiac Adult	N	N	N	Note 2
Cardiac Pediatric	N	N	N	Note 2
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N	Note 2
Other (specify)***	N	N	N	Note 1, Note 2
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance

(PL&ASE DO NOT WATERS OW Achte 1.64 Concurrence of CDRE, Office of Device Evoluntion(ODE)

Pressentation USD (Par 21 CFR.
801.109)

h. DOK
Christian Blen-Ott

Division at Rockon Sign Only City of in Viseo Disampeda Chryse Melocano and Sefuly

510x k11342

0030

Assan B. Goddstein-Falk

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

11/28/2011 00:01 FAX 8484295846

۲۰ NU. 1241

NOV. 29. 2011 1:44PM

Diagnostic Ultrasound Indications for Use Form Transchoer 赛

Frankshis Model:

Number (3)

ACTICA

Clinical Application	B	M	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal			P	Note 2
Abdominal	P	P
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic				P	Note 2
Pediatric	P	P
Small organ (specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P		P	Note 2
Musculo-skeletal Superficial
Intravascular				P	Note 2
Cardiac Adult	P	P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac					Note
Peripheral Vascular	P	P		P
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance

(FLBASE DO NO NORH, Office of Doviev Evelastian(ODDE)

Prosctiption USE (Par 2 ) CFR 801-109)

ﺴ

MALLORY D. OFF

and and the

SIOK 4352

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

11/29/2011 @0:01 FAX 9494295B46 NOV. 29. 2011 1:44PM

004/011

NOV. 29. 2011 1:44PM

Diagnastic Ultrasound Indications for Use Barn Transduscr 개

System Model:

910();) Number(s)

35CSGRE - In 155

Clinical Application	B	M	Combined(specify)	Other (specify)
Ophthalmic
Fetal	N	N	N	Note 1, Note 2
Abdominal	N	N	N	Note 1, Note 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	Note 1, Note 2
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalConventional	N	N	N	Note 1, Note 2
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	N	N	N	Note 1, Note 2

we other use includes Urology_ Note I: Tissue Hornonia limaging. The formers does not use contrast agents.

Note 2: Blapsy Guiduzes

(PLEASEDO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrents of CDRH, Office of Devies Evaluation(GDB)

Prosuription USE Car 21 CFR 601.109

Marshal Dillah

on of house POST Viso Dischoolio Device Exalcation and Solesy OTHOS CHAN

STOK L 113153

1 Bell

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

11/29/2011 00:02 FAX 19494295848 11 1 1 Susan D 1601Østein-Falker 1

Susan Q. Goldstein-Falk

@008/011

30V. 29. 2011 1:44PM

Blagantic Ultrasound Indications for Use Form Trensdicer ×

SystemModal:	65EC10RB						Transducer
510(k) Number(s)	K43153
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic								Note 2
Fetal	N	N					N	Note 2
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ (specify)**							N	Note 2
Neonatal Cephalic	N	N					N	Note 2
Adult Cephalic								Note 2
Trans-rectal	N	N					N	Note 2
Trans-vaginal	N	N					N
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular							N	Note 2
Other (specify)***	N	N
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Pressiption USE (Fer 21 CFR 80L 109)

હ્ય છાર્

M. L. O'Dell

Bander and of Read Section Office of in Viro D on east Group

K11232

0034

Brand States of Children

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

System

Dingmostic Clarasound Indications for Use Form Transdocket

SELLATE

NOV. 29. 2011 1:44 PM

uu. 1741

મ

Model:	65EL60EA
510(k) Number(s)	K113152

Clinical Application	B	M	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic	P	P	P	Note 2
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	Note 2
Other(specify)***

New indication: P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ=breast, thyroid, testis.

***Other can includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

Proscription USE (Por 21 CPR 801.109)

Division Sign-Off

Dogsino of Rad Chica

SIOK K112653

0035

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

11/29/2011 00.02 FAX 9494295846

. . . .

System

1 på 1

لقارة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقاومة المقا

: :

NOV. 29. 2011 1:45PM

리뷰 - 대표 - 1975 - 147

Disquostic Ukrareand Indications for Use Form Trunsmoer - Se

	Mode of Operation
Clinical Application	B	M	FWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal							N	Note 2
Abdominal	N	N
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic							N	Note 2
Pediatric	N	N						Note 2
Small organs (specify)**	N	N					N	Note 2
Neonatal Cephalic	N	N
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)							N	Note 2
Musculo-skeletal Conventional	N	N					N	Note 2
Musculo-skeletal Superficial	N	N
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac							N	Note 2
Peripheral Vascular	N	N
Other (specify)***
N=new indication; P=previously cleared by FDA; *added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance

Copaurement of CDRH, Office of Device Evelusion(ODE)

Preseription USB (Per 21 CFR 801-109)

Aad OJK
(Citizen Sign-On)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

sick K13153

0036

ਤਿੰਦਾ ਹੈ।

and and the state of the starter

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11 - 11:41 - 11

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

ਾ ਦੀ ਸੀ।

,第二十

1947

SymonModel:	751.53EA
510(k) Number(s)	K1/3153

Clinical Application	B	M	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P	P	Note 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	Note 2
Small organ(specify)**	P	P	P	Note 2
Neonatal Cephalic	P	P	P	Note 2
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card)
Musculo-skeletal Conventional	P	P	P	Note 2
Musculo-skeletal Superficial	P	P	P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	Note 2
Other (specify)***

N=new indication; P=previously cleared by FDA; B=added under Appendix E

Additional comments: Combined modes: B+M.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRE, Office of Device Evaluation (ODE)

Proses prion USE (Por 21 CFR 801.109)

Mr. A. O. Dike

Division of Radiological Devices
Bureau of on Vitro Diagnostic Device Evaluation and Safety

sick E 113/51

0037

11 11:42 1

1135 - - 5 pharal Socied hat hand - a - a r d min 4 i = = ( . + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +

000/800 00

Allen and the

く:

13,100

Alley-uterspiros . 0 uesus

元年度时 8685526596 00 00 Proversity Search on the first the mind the mind the mail of the

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

NOV. 29. 2011 3:13PW

이 대한 이상 등 1

and the comments of the comments of the comments of the

的主要最新的位置

ਸਿੰਘ ਸੀ। ਇਸ ਦੀ ਸਾਰੇ ਦੇ ਮੁ

ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

이 대한 사용

1941 - 1944

11,97

Diagnostic Ultrasound Indications for Use Form

System
Model	TSLT3REA
510(k) Number(s)	5113153

Transducer

Mode of Operation

Clinical Application	B	M	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	Note 2
Intraoperative (specify)*	P	P	P	Note 2
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	Note 2
Small organ (specify)**	P	P	P	Note 2
Neonatal Cephalic	P	P	P	Note 2
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card.)
Musculo-skeletal Conventional	P	P	P	Note 2
Musculo-skeletal Superficial	P	P	P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Trans-Cardiac
Peripheral Vascular	P	P	P	Note 2
Other (specify)****

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORE, Office of Device Evaluation (ODE)

Preseription USC (Per 21 CFR 801.109)

Arda D.K.
[signature]

Offica and Smary

DTOR K113153

0038 11:51 11

1 - 1

문의 대학교 대학

8985829898 88 FAJ BP Fra BP:00 FLO2762111 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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

11/28/2011 00:21 FAX 9494295848 XDV. 29. 2011 1:53PM

国001/014

P. 13/24 NO. 124 /

Dingnostia Ultrassund Indications for Use Form Transquaer

DP-30

11:316

gyestu ?નવીધી:
510(g) Number(s)

Clinical Application	B	M	Combined(specify)	Other (specify)
Ophthalmic	N	N	N	Note 1, Note2
Fetal	N	N	N	Note 1, Note2
Abdominal	N	N	N	Note 2
Intraoperative (specify)*	N	N
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	Note 1, Note 2
Small organ(specify)**	N	N	N	Note 2
Neonatal Cephalic	N	N	N	Note 2
Adult Cephalic	N	N	N	Note 2
Trans-rectal	N	N	N	Note 2
Trans-vaginal	N	N	N	Note 2
Trans-urethral
Trans-esoph(non-Card.)			N	Note 1, Note 2
Musculo-skeletalConventional	N	N	N	Note 2
Musculo-skeletal Superficial	N	N
Intravascular			N	Note 2
Cardiac Adult	N	N	N	Note 2
Cardiac Pediatric	N	N
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac			N	Note 2
Peripheral Vascular	N	N	N	Note 1, Note 2
Other (specify)***	N	N	-N	Note 1, Note 2

Intervention includes abdominal, thoracic, and

at Small ongag-breast, thyroid, tastes.
xxx (Jiber ust meludes Urolagy.

Note 1. Tissue Hornomio Ilmiging, The feature doos nor use nontrast agains.

Note I; Biopsy Guidence

810

(FLBASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(FLBASE DO NOT WRITE BELLOW Concurrante of CDRH, Office of Device Evalustian(ODE)

Prestoritstica USE (Par 21 CFR 801-109)

Marth D. Kirk

Division Sign-Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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

Dingnoote Clerasound ladications for Use Form Tasistadiaat

欧002/014

P. 16/24

System	35C205A
Model:
510(K) Number(s)	K113153

Clinical Application	B	M	Combined (specify)	Other (specify)
Ophthalmic
Femoral
Abdominal	P	P	P	Note 2
Intraoperative (specify)*
Invasive/Interventional (Neuro)
Laparoscopic
Pediatric	P	P	P	Note 2
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card.)
Musculo-skeletal Conventional	P	P	P	Note 2
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	Note 2
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	Note 2
Other (specify)***

N=new indication: P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Presentpeion USE (Per 21 CPR 801.109)

ﻬﻢ ﺍﻟﻤﺘﺤﺪﺓ

Mashad R. J.M.

State As Subly office of the STITUTE ARD .

න්නේ පිහිටා විසින් පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි පිහිටි පිහිටි බවට පිහිටි

SIOK K113/53

0040

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

11/28/2011 00.22 FAX 94942956146

0003/014

NOV. 29. 2011, 1:53PM

Dingnostic Uttrasonad Indications for Use Form

Transdates *

System Modal: 510kk) Nizabea (s)

35 50RA 113157

Clinical Application	B	M	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	Note 1, Note 2
Abdominal	P	P	P	Note 1, Note 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	Note 1, Note 2
Small organs (specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalConventional	P	P	P	Note 1, Note 2
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)	P	P	P	Note 1, Note 2

Pressuiption USE (Par 21 CFR 801 109)

1. No. 1. 1.

Ars. A. DDA
[Director Sign-Off]

Division of Realding and Dentose Office of In Unite Disamostic Device Element

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

k 11311 510K,

0041

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

11/29/2011 00:22 FAX 8484295846

团 004/014

HCV. 29, 2011 1:59PM

Diagagene Ultrasonnd Indications for Use Form antinas ਮ

System Modal: 510() Number (s)

65CLSEA
511315

Clinical Application	B	M	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P		Note 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic			P	Note 2
Pediatric	P	P
Small organ(specify)**			P	Note 1
Neonatal Cephalic	P	P	P	Note 2
Adult Cephalic	P	P	P	Note 2
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P	Note 2
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric	P	P	P	Note 2
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	Note 2
Other (specify)***
Notes: Indication; P=previously cleared by FDA, E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other are includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Presentption USB (Per 21 CFR 80J.109)

، • • ﺳﻢ

Puss D'H

Oversion of Radiolor Citics of in Boon gives Sinters

6103/53

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

11/28/2011 00.22 Fax 9494285846 NOV. 29. 2011 1:59PM

1974 - 1

NU. 1241 - 124 11/24

团 005/014

이 지원할 수

2.3.2.2.11 3-1131

Diagnostic Ultrasound Indications for Use Form
Transducer
65PC10EA

K 113123

Model: 510(k) Number(s)

System

1, 201

在线上

我要的一个人

Clinical Application	B	M	PWD	Combined(specify)	Other(specify)
Ophthalmic	P	P		P	Note 2
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ (specify)**
Neonatal Cephalic	P	P	P	P	Note 2
Adult Cephalic
Transrectal	P	P		P	Note
Trans-vaginal	P	P		P	Note
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P		P	Note
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ=breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance

Preseription USB (Per 21 CFR 801 109)

SICK.

a 2017 - 1

A. A. D'A

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0043

ਦਾ ਦੀ ਉਸਦੇ ਦਾ ਸਾਂ ਅੰਤਿਆ ਸੀ। ਇਸ ਦੇ ਸ

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

11/28/2011 00:22 FAX 99904285846

团 006 /0 14

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

NOV. 29 2011 1:55PM

r. 16/ 14 110. 1141

Diagnostic Ultrasound Indications for Use Form

Transducer	x
------------	---

11 2016 6. 00-6-6System Model: 510(k) Number(s)

65BLOUDA 6113158

Clinical Application	B	M	Combined(specify)	Other(specify)
Ophthalmic
Foni
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Transrectal	P	P	P	Note 2
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P	Note
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Preseription USE (Por 2) CBR 801.109)

A. L. D. D. K.

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

312

09:51:5

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

11/29/2011 00:22 FAX 8484285846

137

NOV. 29. 2011 1:59PM

Dinganstic Citrasound Indications for Use Form Transducer 14

Model:	66EB10EA
510(k) Number(s)	K1613153

Clinical Application	B	M	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Femoral
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ (specify)**
Neonatal Cephalic
Adult Cephalic			N	Note 2
Trans-rectal	N	N
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	N	N		N	Note 2

N=new indication; P=previously cleared by FDA; Bradded under Appendix E

Additional comments:Combined modes: B+M.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRJI, Office of Device Evaluation(ODE)

BLOK.

Posstarty doo USB (Por 21 CFR 801.109)

Ress DDK

Chicon of Rack the Brahaman will SSIALY Office of in Viro Dis France France

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

r. Lucity NU. 1241

1 - 59 PM NOV. 29. 2011

Dingnostic Ultrasound Indications for Use Form Transducer ਮ

System Model: SIOUs) Namaker (s)

SECTORD CITY 153

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	N	N					N	Note 2
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ (specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal	N	N					N	Note 2
Transurethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Extra-Cardiac
Peripheral Vascular
Other (specify)***

N=new indication; F=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes: B+M

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Pressiptive USE (Por 21 CFR 801.109)

ﺔ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

M.L.D.D.A.
[Mission Plan-Out]

Orvision of Radiological Dav and 18577 offen at in Vitre Disgrosms Davice

Stok K10153

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

11/28/2011 00:22 FAK 9494295846

۲۰ 19124 NU. | LA 1

NOV. 29, 2011 1:59 PM

Dlagnostic Curasound Indications for The Form Transdaoer メ

System Madel:

5100k) Number (8)

791.380 A (((1)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(2)(

Clinical Application			B	AmplitudeDoppler	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	Note 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic					Note 2
Podiatric	P	P		P	Note 2
Small organ(specify)**	P	P		P	Note 2
Neonatal Cephalic	P	P		P	Note 2
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(ans-Card.)
Musculo-skeletal Conventional	P	P		P	Note 2
Musculo-skeletal Superficial	P	P		P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P		P	Note 2
Other (specify)***

Pressiption USE (Por Z) CFR 801.109)

Fri .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Jassh D. H

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

કાવત

0047

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

10:24

. LLILY : 上一篇:

XOY. 29. 2011 2 . 00PM

Diagnastic Ultrasound Indications for Use Form Transchucer ਨੇ

System Model: 510(2) Number(3)

110

731.53EA 11315

Clinical Application	B	M	FWD	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal				P	Note 2
Abdominal	P	P
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic					P	Note 2
Pediatric	P	P	P		P	Note 2
Small organ (specify)**	P	P	P		P	Note 2
Neonatal Cephalic	P	P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (incl. Card.)
Musculo-skeletal Conventional	P	P	P		P	Note 1
Musculo-skeletal Superficial	P	P	P		P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P			P	Note
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Preseription USP. (Par 21 CFR, 801.109)

ﮨﯽ

notw ten Siber Off

philipp of Fistic sains Devi Devon Erstustion and Salety affec of the asso Demosta

9102 113153

0048

,拥出版。

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

11/29/2011 00:23 FAX 8484295846

Susan O Goldstoin-Falk

团011/014

r. Zille 40. 1241

NOV. 29. 2011 2:00PM

Diagnestic Ultrusound Indications for Die Form メ

System Model:

510(k) Number(s)

Tresscients 75LT38EA KITS 153

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P					P	Note 2
Intraoperative (specify)*	P	P					P	Note 2
Intraoperative (Neuro)
Laparoscopic
Podiatric	P	P					P	Note 2
Small organ(specify)**	P	P					P	Note 2
Neonatal Cephalic	P	P					P	Note 2
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P					P	Note 2
Musculo-skeletal Superficial	P	P					P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P					P	Note 2
Other (specify)***

Pressipilon USE (Per 21 CPR 801-109)

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Aall DDK
(Division Signed)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

K03152

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

11/28/2011 00:23 FAX 8484295848

Susan D. Boldstein-Falk

团 012/014 HU. 1241 1. 23/24

Dirghostic Ultrasound Indicutions for Die Form x

System Model: 5100k) Pounder(s)

Transducer
75LT98EA
KI13153

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P					P	Note 2
Intraoperative (specify)*	P	P					P	Note 2
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P					P	Note 2
Small organ(specify)**	P	P					P	Note 2
Neonatal Cephalic	P	P					P	Note 2
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P					P	Note 2
Musculo-skeletal Superficial	P	P					P	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P					P	Note 2
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE < CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrents of CDRH, Offica of Devise Evaluation(ODE)

Pressiption USE (Per 21 CPR 201.109)

i :

A.A.D.K.

SEMBERT Official of Auction Evaluation end Serbo Office of In Viro Dieg

510K KU345

0049

88 - 电子 - 视频

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

11/29/2011 00:23 TAX 3484285846 NOV. 29. 2011 2:00PM

团013/014

NU. 1241 4. 24/24

・

Diagnostic Ultrasonad Indications for Uso Farm Transducer K

System Modol: 510(T) Number(s)

20124BA CITERSER

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric						N	Note 2
Small organ (specify)**	N	N	N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (neo-Card.)
Musculo-skeletal Conventional	N	N	N			N	Note 2
Musculo-skeletal Superficial	N	N	N			N	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N			N	Note 2
Other (specify)***

Concurrents of CDRH, Office of Device Evaluation(ODE)

Prossignbon USE (Per 21 CPR 801.109)

Badd Dida
Division Sign-Off

Disco Offics of in Vit an and Secar

SSK. 4/13/23

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

1 035

NOV. 29. 2011 2:00PM

Diagnostic Ultrasqund Indications for Use Form メ Treesducer

System Model:

510() Nusber(s)

101-245A CIT 3153

Clinical Application	Mode of Operation
	B	M	FWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (speci(y))*
Intraoperative (Neuro)
Laparoscopic
Pediatric							N	Note 2
Small organ(specify)**	N	N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)							N	Note 2
Musculo-skeletal Conventional	N	N					N	Note 2
Musculo-skeletal Superficial	N	N					N	Note 2
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac							N	Note 2
Peripheral Vascular	N	N					N	Note 2
Other (specify)***
New indication: Previously cleared by FDA; Added under Appendix B
Additional comments: Combined modes B+M.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Proseription USB (Por 2) CFR 801. 109)

Bledsoe

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K ALLAS

0850

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.