K Number
K103583
Device Name
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
Date Cleared
2010-12-27

(20 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.
Device Description
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.
More Information

No
The document describes a standard ultrasound system with various imaging modes and probes. There is no mention of AI, ML, or related concepts in the device description, intended use, or any other section. The modifications mentioned are related to additional transducers and image enhancement features, which are typical for ultrasound systems and do not inherently imply AI/ML.

No.
The device is described as a "Diagnostic Ultrasound System" intended for acquiring and displaying images of anatomical structures and fluid flow within the body, which is for diagnostic purposes, not therapeutic intervention.

Yes

The "Intended Use / Indications for Use" section explicitly states "The DC-7 Diagnostic Ultrasound System".

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and employs "an array of probes" which are hardware components essential for acquiring ultrasound data. While it is "software controlled," it is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as a "Diagnostic Ultrasound System" used for imaging various anatomical sites within the body. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
  • Device Description: The description focuses on the ultrasound technology, probes, and imaging modes (B-mode, M-mode, Color mode, etc.). These are all characteristics of an in-vivo imaging system.
  • Mentions image processing: The image processing described is for generating on-screen displays of structures within the body.
  • Input Imaging Modality: Ultrasound is an in-vivo imaging modality.
  • Anatomical Site: The listed anatomical sites are all locations within the human body.

IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This device operates by sending and receiving ultrasound waves to create images of internal structures, which is a fundamentally different function.

N/A

Intended Use / Indications for Use

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.

Product codes

IYN, IYO, ITX

Device Description

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.

This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates.

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s)

K101041, K091941, K061682, K060542, K032974, K050240, K052410, K060993

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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: ( 03583

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

Contact Person:

Meng Xianjun 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 5640 Fax: +86 755 2658 2680

Date Prepared: Sept. 25, 2010

2. Device Name: DC-7 Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Predicate Device(s):

DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices. 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.

1

| Predicate

DeviceManufacturerModel510(k) Control Number
1MindrayDC-7K101041
2MindrayDC-3K091941
3GEVoluson E8K061682
4GEVIVID 7K060542
5GELOGIQ5 ExpertK032974
6SiemensAcuson CV70K050240
7SiemensAcuson Sequoia 512K052410
8GELOGIQ P5K060993

4. Device Description:

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.

This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.

5. Intended Use:

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.

6. Non-clinical Tests:

DC-7 Diagnostic Ultrasound 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, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 and ISO 10993-1.

7. Technological Characteristics:

The DC-7 Diagnostic Ultrasound System has the same technological characteristics with the predicate devices. All systems transmit ultrasonic energy into patients, then perform

2

post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

7.Conclusion:

The DC-7 Diagnostic Ultrasound System has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices.

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, ISO9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-7 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

DFC 2 7 2010

Re: K103583

Trade/Device Name: DC-7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 3, 2010 Received: December 7, 2010

Dear Mr. Rongero:

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 DC-7 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5AL12-4P7-3
C5-2L7-3P12-4
V10-4L11-47LT4
V10-4BL14-6DE10-3
6C22P26LB7
7L4A4CD46LE7
7L5P4-2CB10-4

4

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 Paul Hardy at (301) 796-6542.

Sincerely yours.

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

K(.03S8-3

Indications for Use

510(k) Number (if known):

DEC 2 7 2010

Device Name: DC-7 Diagnostic Ultrasound System

Indications For Use:

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women,pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal; transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial}, intraoperative, and urology exams.

Prescription Use __x

AND/OR

ﺎ Over-The-Counter ﺎ

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subp

Page 1 of _1

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

510K K103583

008-1

6

SystemXTransducer
Model:DC-7
510(k) Number(s)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPPNote 1,2, 3, 4,6,7
AbdominalPPPPPPPNote 1, 2, 3, 4,5,6
Intraoperative (specify)*PPPPPPPNote 1,2, 4,6,7
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2, 4,5,6,
Small organ(specify)**PPPPPPPNotel, 2, 4,6,7
Neonatal CephalicPPPPPPPNotel, 2, 4,5,6,7
Adult CephalicPPPPPPPNotel, 2, 4,5,6,7
Trans-rectalPPPPPPPNote 1,2,3,4,6,7
Trans-vaginalPPPPPPPNote 1,2,3,4,6,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal ConventionalPPPPPPPNote 1,2,4,6,7
Musculo-skeletal SuperficialPPPPPPPNote 1,2,4,6,7
Intravascular
Cardiac AdultPPPPPPPNote 1,2,5,6,7
Cardiac PediatricPPPPPPPNote 1,2,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPPNote 1,2,4,6,7
Other (specify)***NNNNNNNNote 1,2,4,6,7
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M

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

i

. .

Prescription USE (Per 21 CFR 801.109)


(Division Sign Off)

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

510K K163583

7

Image /page/7/Figure/0 description: The image shows the text "Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System". The text appears to be a product name or a company name and product description. The text is written in a simple, sans-serif font and is horizontally aligned. The text is likely part of a product label, advertisement, or informational material related to medical equipment.

Model:3C5A
510(k) Number(s)
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2, 4,6,
AbdominalPPPPPPNote 1, 2, 4,6,
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1, 2, 4,6,
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1, 2, 4,6,
Musculo-skeleta! Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1, 2, 4,6,
Other (specify) **
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
* * Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D.
Note 3:4D(Real-time 3D) ´---
Note 4: iScape
Note5: TDI
Note6: Color M

Transducer

×

Model:

008-3

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological D

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

510K

System

8

. "

Prescription USE (Per 21 CFR 801.109)

Model:CS-2TransducerX
510(k) Number(s)
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2, 4,6
AbdominalPPPPPPNote 1, 2, 4,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1, 2, 4,6
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1, 2, 4,6
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1, 2, 4,6
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D).
Note 4: iScape
Note 5: TDI
Note6: Color M
Note7: Biopsy Guidance

Diagnostic Ultrasound Indications for Use Form ﺍﻟﺨﺪﺍﻡ ﺍﻟ

'Transducer

×

System

Concurrence of CDRH, Office of Device Evaluation(ODE)

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

510K K103583

008-4

9

·

:

Mode of Operation
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPNote 1, 2, 4,6,7
Trans-vaginalPPPPPPNote 1, 2, 4,6,7
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)***NNNNNNNote 1,2,4,6,7

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103583510K

Diagnostic Ultrasound Indications for Use Form

V 10-4

Transducer

×

System Model:

008-5

.

10

| : :

  • | ్రాల్యేక | ี | |
    |----------|----------|---|--|
    | | | | |
    | | | | |

Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System

SystemTransducerX
Model:V10-4B
510(k) Number(s)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPNote 1, 2, 4,6,7
Trans-vaginalPPPPPPNote 1, 2, 4,6,7
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)***NNNNNNNote 1,2,4,6,7

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

  • Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

| Prescription USE (Per 21 CFR 801.109) | (Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety |

--------------------------------------------------------------------------------------------------------------------------------------------------------------

510K. K103583

Diagnostic Ultrasound Indications for Use Form

י

:

008-6

11

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

System Model:

. : Transducer × ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------6C2

510(k) Number(s)

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPNote 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1, 2, 4,6,7
Small organ(specify)**
Neonatal CephalicPPPPPPNote 1, 2, 4,6,7
Adult CephalicPPPPPPNote 1, 2, 4,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalEPPPPPNote 1, 2, 4,6,7
Musculo-skeletal SuperficialEPPPPPNote 1, 2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1, 2, 4,6,7
Other (specify)***

Prescription USE (Per 21 CFR 801.109)


510K

5582

008-7

12

: -

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System Model:

Transducer ×

5 ! 0(k) Number(s)

7L4A

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPNote 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1,2, 4,6,7
Small organ(specify)**PPPPPPNote 1,2, 4,6,7
Neonatal CephalicPPPPPPNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1,2, 4,6,7
Musculo-skeletal SuperficialPPPPPPNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1,2, 4,6,7
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B,
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology:
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4 iScape
Note5 : TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801,109)

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

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

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

510K K103583

008-8

13

7L5

System Model:

Transducer ×

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Felal
AbdominalpPPPPpNote 1,2, 4,6,7
ntraoperative (specify)*
ntraoperative (Neuro)
aparoscopic
PediatricPPPPPPNote 1,2, 4,6,7
Small organ(specify)**PPPPPPNote 1,2, 4,6,7
Neonatal CephalicbPPPPPNote 1,2, 4,6,7
1 :
Adult Cephalic: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :. -
r
Trans-rectalTexas P
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card.)
Musculo-skeletal ConventionalPPPPPpNote 1,2, 4,6,7
Musculo-skeletal SuperficialPPPPPPNote 1,2, 4,6,7
ntravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1,2, 4,6,7
Other (specify)***
V=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW+B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
** * Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Notes: TDI
Note6: Color M: '
Note7: Biopsy Guidance្រះ
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

. :

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

Prescription USE (Per 21 CFR 801.109)

(Division of Radiological Devioss

510K K103583

14

Transducer

×

:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

L 12-4

.

. .

System Model:

510(k) Number(s)

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
|----------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | |
| **Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Smart3D | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | |
| Note 4: iScape | | | | | | | | |
| NoteS: TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 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 Radiological Devioss
Office of In Vito Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103583

15

L7-3

System Model:

Transducer

×

510(k) Number(s)

Mode of Operation Clinical Application Combined Color Amplitude PWD CWD Other (specify) B M Doppler Doppler (specify) Ophthalmic . . . . Fetal Note 1,2, 4,6,7 Abdominal P P P P P P Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic p P P Note 1,2, 4,6,7 Pediatric P P P P P P P P P Note 1,2, 4,6,7 Small organ(specify)** P P Note 1,2, 4,6,7 Neonatal Cephalic P P P P Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph (non-Card.) P Musculo-skeletal Conventional p P P P Note 1,2, 4,6,7 P P Note 1,2, 4,6,7 P P P P Musculo-skeletal Superficial P Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) י Trans-esoph (Cardiac) Intra-Cardiac P P P Note 1,2, 4,6,7 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, PW+B, Color + B, PW+Color+ B, PW +Color+ B, Power + PW+B. * Intraoperative includes abdominal, thoracic, and vascular etc. * * Small organ-breast, thyroid, testes, etc. ... ***Other use includes Unology Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape Note5: TDI Note6: Color M Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 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 Radiological Devices vice Evaluation and Safety office of In

510K. K103583

16

L | 1-4

System Model: Transducer ×

510(k) Number(s)

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (specify) |
|----------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Other (specify)*** | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | |
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | |
| **Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | |
| Note 2: Smart3D | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | |
| Note 4: iScape | | | | | | | | |
| Note5 : TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7 : Biopsy Guidante | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |

Prescription USE (Per 21 CFR 801.109)

, ' ﻨ

. . : : 1

:

Signature

(Division of Rediological Devices

510K K103583

17

Image /page/17/Picture/0 description: The image shows a scattering of small, irregular black shapes against a white background. The shapes are concentrated in two distinct clusters, one on the left side of the image and another on the right. The shapes appear to be randomly distributed, with no discernible pattern or structure within each cluster.

L 14-6

System Model:

Transducer

×

SIO(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPNote 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1,2, 4,6,7
Small organ(specify)**PPPPPPNote 1,2, 4,6,7
Neonatal CephalicPPPPPPNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1,2, 4,6,7
Musculo-skeletal SuperficialPPPPPPNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 1,2, 4,6,7
Other (specify)***

Concurrence of CDRH, Office of Device Evaluation(ODE)

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Prescription USE (Per 21 CFR 801, 109)

: ............................................................................................................................................................................ . ; . -. :

(Division Sign-Off)
Division of Radiological Devioes Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103583

18

:

Diagnostic Ultrasound Indications for Use Form

System Model:

Transducer × 2P2

510(k) Number(s)

.


Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1, 2,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2,5,6,7
Small organ(specify)**
Neonatal CephalicPPPPPPPNote 1, 2,5,6,7
Adult CephalicPPPPPPPNote 1, 2,5,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPPNote 1, 2,5,6,7
Cardiac PediatricPPPPPPPNote 1, 2,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

·

19

Model:4CD4
510(k) Number(s)
Clinical ApplicationMode of Operation
BMPW DCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1,2, 3, 4,6
AbdominalPPPPPPNote 1,2, 3, 4,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote1,2, 4,6
Small organ(specity)**
Neonatal Cephalic
Adult Cephalic
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
Other (specify)***

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division of Rediological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety

1 2 1 : 1 :

L

210K

:

Diagnostic Ultrasound Indications for Use Form

Transducer

X

System Model:

008-15

20

Image /page/20/Picture/0 description: The image shows a sparse distribution of black dots against a white background. The dots are concentrated more densely on the left side of the image, forming a cluster. As one moves to the right, the dots become more scattered and isolated, with larger gaps between them.

System Model:

Transducer P4-2

×

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPW
DCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1, 2,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2,5,6,7
Small organ(specify) **
Neonatal CephalicPPPPPPPNote 1, 2,5,6,7
Adult CephalicPPPPPPPNote 1, 2,5,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPPNote 1, 2,5,6,7
Cardiac PediatricPPPPPPPNote 1, 2,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801 رام 1. 109)

-- :

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103583

008-16

21

Image /page/21/Picture/0 description: The image shows a scattering of small black dots and dashes against a white background. The dots are clustered in the upper left quadrant, with a few isolated dots elsewhere. The dashes are vertical and appear in the lower center of the image. The overall impression is one of sparse and random distribution of these simple graphic elements.

SystemTransducerX
Model:P7-3
510(k) Number(s)
Clinical ApplicationBMPW DCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1, 2,5,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2,5,6
Small organ(specify)**
Neonatal CephalicPPPPPPPNote 1, 2,5,6
Adult CephalicPPPPPPPNote 1, 2,5,6
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1, 2,6
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPPNote 1, 2,5,6
Cardiac PediatricPPPPPPPNote 1, 2,5,6
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

4103583

510K-

Diagnostic Ultrasound Indications for Use Form Transducer

008-17

.

22

System
Model:P12-4
510(k) Number(s)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1, 2,5,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2,5,6
Small organ(specify)**
Neonatal CephalicPPPPPPPNote 1, 2,5,6
Adult CephalicPPPPPPPNote 1, 2,5,6
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 1, 2,6
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPPNote 1, 2,5,6
Cardiac PediatricPPPPPPPNote 1, 2,5,6
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)


System

Transducer

(Division Sign-Off)

ಿ ದ

చిక్

: '

કાબ્રત

23

Image /page/23/Picture/0 description: The image shows a scattering of small, dark spots against a white background. The spots are concentrated in the left portion of the image, forming a cluster. As the view moves to the right, the spots become more sparse and isolated.

7LT4

Diagnostic Ultrasound Indications for Use Form

System Model: Transducer

×

510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColorAmplitudeCombined
DopplerDoppler(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1,2, 4,6,7
Intraoperative (specify)*PPPPPPPNote 1,2, 4,6,7
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1,2, 4,6,7
Small organ(specify)**PPPPPPPNote 1,2, 4,6,7
Neonatal CephalicPPPPPPPNote 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPPNote 1.2, 4,6,7
Musculo-skeletal SuperficialPPPPPPPNote 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPPNote 1,2, 4,6,7
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B,
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note6: Color M
Note 7 : Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2,3, 4,6
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPNote 1, 2, 3,4,6
Trans-vaginalPPPPPPNote 1, 2, 3,4,6
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=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6 Color M
Note7 Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・ Prescription USE (Per 21 CFR 801.109)

510K

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

24

Diagnostic Ultrasound Indications for Use Form
-------------------------------------------------------

System Model:

Transducer × . . . . . ் - DE10-3 · :
... " : ; :"

510(k) Number(s)

!!!

Prescription USE (Per 21 CFR 801.109)

510K

(Division of Radiotogical Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety

008-20

25

SystemTransducerX
Model:6LB7
510(k) Number(s)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNNote 1, 2, 4,6,7
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)***NNNNNNNote 1,2,4,6,7

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B,

  • Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

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

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 4: iScape Note5: TDI Note6: Color M

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

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

26

Diagnostic Ultrasound Indications for Use Form

SystemTransducerX
Model:6LE7
510(k) Number(s)

्र के बाद में दिन में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**:
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNNote 1, 2, 4,6,7
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) ** *NNNNત્વNNote 1,2,4,6,7
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, Power + PW+B,
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
** * Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

510K.

(Division Sign-Off)
Division of Radiological Devices

・・

008-22

(Division of Radiological Devioss

27

Transducer System × יי Model: CB10-4 . 510(k) Number(s)

Mode of Operation Clinical Application Amplitude Color Combined CWD B M PWD Other (specify) Doppler Doppler (specify) Ophthalmic Fetal Abdominal Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric Small organ(specify)** Neonatal Cephalic :・ Adult Cephalic Trans-rectal N N N N N N Note 1, 2, 4,6,7 Trans-vaginal Trans-urethrai 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 1,2,4,6,7 Other (specify) *** N N N N N N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments:Combined modes: B+M, PW+B, Color + B, PW+Color+B, PW +Color+B, Power + PW+B. * Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. *** Other use includes Urology. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape Note5: TDI Note6: Color M Note7: Biopsy Guidance (PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE 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 Radiological Devices Office of Ir The Color of Haulorogical Devices
Vitro Diagnostic Device Evaluation and Satel,

810