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K Number
K091941
Device Name
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Date Cleared
2009-07-09

(9 days)

Product Code
ITXIYNIYO
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, and musculoskeletal, perficial vascular, exams exams.
Device Description
The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. It function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, DirPower 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, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.
More Information

K083505, K080640, K072164, K041688

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and probe types.

No
The device is described as a "Diagnostic Ultrasound System" intended for "ultrasound evaluation" and generating images in various modes, which are diagnostic functions, not therapeutic.

Yes
The device description explicitly states it is a "Diagnostic Ultrasound System" and its function is to acquire and display ultrasound images for various medical evaluations.

No

The device description explicitly states it is a "general purpose, mobile, software controlled, ultrasound diagnostic system" and mentions employing "an array of probes." This indicates the device includes hardware components (the ultrasound system and probes) in addition to the software control.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
  • Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Intended Use: The intended use describes ultrasound evaluations of various anatomical sites within the body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, and musculoskeletal, perficial vascular, exams exams.

Product codes

IYO, IYN, ITX

Device Description

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. It function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, DirPower 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, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, musculoskeletal, perficial vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician

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)

K083505, K080640, K072164, K041688

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

0

JUL - 9 2009

K091941

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 §801 13 Donny

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter:

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

Tel: +86 755 2658 2888 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: May 26, 2009

  1. Device Name: DC-3/DC-3T Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-TYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-11

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the original DC-3/DC-3T Diagnostic Ultrasound System that is already cleared under premarket notification number K083505, and the other predicate devices are listed below: Mindray M5 (K080640), Mindray DC-6 (K072164),GE Voluson 730(K041688),

1

4. Device Description:

The DC-3/DC-3T Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. It function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode, DirPower 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, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

5. Intended Use:

The device is intended for use by a qualified physician for ultrasound evaluation of gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedial, and musculoskeletal, perficial vascular,
exams exams.

6. Safety Considerations:

The DC-3/DC-3T Diagnostic Ultrasound System has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Standards, such, as JEC 6004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

2

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing a person or a bird.

JUL = 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K091941

Trade/Device Name: DC-3/DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 24, 2009 Received: June 30, 2009

Dear Mr. Mosenkis:

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-3/DC-3T Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C5A ୧୯.୮୮.୧ 7L4A 716 10L4 6C2 6LE7

3

6LB7
3C1
2P2
7L5
7LT4
D6-2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

Heidi Remer
Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

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Diagnostic Ultrasound Indications for Use Form

Transducer

DC-3/DC-3T

System Model:

510(k) Number(s)

Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalPPPPPPPNote 1, 2, 3, 4
AbdominalPPPPPPPNote 1, 2, 3, 4
Intraoperative (specify)*PPPPPPPNote 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1, 2, 3, 4
Small organ(specify)**PPPPPPPNote 2, 3, 4
Neonatal CephalicPPPPPPPNote 1, 2, 3, 4
Adult CephalicPPPPPPPNote 1,2, 3
Trans-rectalPPPPPPPNote 2, 3, 4
Trans-vaginalPPPPPPPNote 2, 3
Trans-urethralNote 2, 3
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 2, 3, 4
Musculo-skeletal SuperficialPPPPPPNote 2, 3, 4
Intravascular
Cardiac AdultPPPPPPPNote 1,2, 3
Cardiac PediatricPPPPPPPNote 1,2, 3
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***PPPPPPNote 2, 3, 4
PPPPPPNote1, 2, 3, 4

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

0085

5

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

3CSA

Transducer

×

System Model: 510(k) Number(s)

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 1, 2, 3
AbdominalPPPPPPNote 1, 2, 3
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 1, 2, 3
Small organ(specify) **Note 1, 2, 3
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 VascularPPPPPPNote 1, 2, 3
Other (specify) ***PPPPPPNote 1, 2, 3
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.
SystemDiagnostic Ultrasound Indications for Use Form
Model:6CVITransducerX
510(k) Number(s)
Clinical ApplicationMode of Operation
BMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 2, 3
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPNote 2, 3
Trans-vaginalPPPPPPNote 2, 3
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) ***PPPPPPNote 2, 3
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: iScape
Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPP
Intraoperative (specify)*PPPNote 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPP
Small organ(specify)**PPPPPPNote 2, 3, 4
Neonatal CephalicPPPPPPNote 2, 3, 4
Adult CephalicPPNote 2, 3, 4
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPP
Musculo-skeletal SuperficialPPPPPPNote 2, 3, 4
IntravascularPPPNote 2, 3, 4
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPP
Other (specify)***PPPNote 2, 3, 4
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: iScape
Note 4: iBeam

Note 2: Smart3D Note 3: iScape

Note 4: iBeam

Hula leum

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

0086

6

Diagnostic Ultrasound Indications for Use Form

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

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Diagnostic Ultrasound Indications for Use Form System Transducer Model: 7L4A 510(k) Number(s) ·

×

Hechd Lewn

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

8

System Transducer × Model: 716 510(k) Number(s) Mode of Operation Clinical Application Color Amplitude B M Combined PWD CWD Other (specify) Doppler Doppler (specify) Ophthalmic Fetal Abdominal P P P P P P Intraoperative (specify)* Note 2, 3, 4 Intraoperative (Neuro) Laparoscopic Pediatric P P P P P Small organ(specify)** P Note 2, 3, 4 P P P P P P Neonatal Cephalic Note 2, 3, 4 P P P P p Adult Cephalic P Note 2, 3, 4 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph.(non-Card.) Musculo-skeletal Conventional P P P P P Musculo-skeletal Superficial P Note 2, 3, 4 P P P P P Intravascular P Note 2, 3, 4 Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-Cardiac Peripheral Vascular P P P P P P Other (specify) ** * Note 2, 3, 4 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 I: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3: iScape Note 4: iBeam

Hes Rem

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

Diagnostic Ultrasound Indications for Use Form

0089

9

Diagnostic Ultrasound Indications for Use Form System Transducer × Model: I OLA 510(k) Number(s) Mode of Operation Clinical Application Color-Amplitude B Combined M PWD CWD Other (specify) Doppler Ophthalmic Doppler (specify) Fetal Abdominal p P P P Intraoperative (specify)* P P Note 2, 3, 4 Intraoperative (Neuro) Laparoscopic Pediatric P P P P P Small organ(specify) ** P Note 2, 3, 4 P P P P P Neonatal Cephalic P Note 2, 3, 4 P P P P Adult Cephalic P P Note 2, 3, 4 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph.(non-Card.) Musculo-skeletal Conventional P P P P Musculo-skeletal Superficial P P P Note 2, 3, 4 P p P Intravascular P P Note 2, 3, 4 Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac Peripheral Vascular p P P P P Other (specify) ** P Note 2, 3, 4 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, 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

Helda Perm

ision Sign Off) on of Reproductive, Abdominal a Radiological Devices 510(k) Number

Note 3: iScape Note 4: iBeam

10

and the comments of the count

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...

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、

System
Model:6C2
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

TransducerX
---------------
Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPNote 2, 3
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 2, 3
Small organ(specify)**
Neonatal CephalicPPPPPPNote 2, 3
Adult CephalicPPPPPPNote 2, 3
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPNote 2, 3
Cardiac PediatricPPPPPPNote 2, 3
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***PPPPPPNote 2, 3.

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: iScape

Note 4: iBeam

(Division Sign-Off)

Division of Reproductive, Abdominal and

Radiological Devices

510(k) NumberK091941
------------------------

0091

.

11

SystemTransducerX
Model:6LE7
510(k) Number(s)
Clinical ApplicationMode of Operation
BMPW
DCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalPPPPPPNote 2, 3, 4
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPP
Trans-vaginalPPPPPPNote 2, 3, 4
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)***PPPPPPPNote2, 3, 4
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: iScape | | | | | | | | |
    | Note 4: iBeam | | | | | | | | |

Diagnostic Ultrasound Indications for Use Form

Hele Keen

(Division Sign off)

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

12

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

System

Transducer X

Model:6LB7
510(k) Number(s)
Clinical ApplicationBMPW DCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPNote 2, 3, 4
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)***PPPPPPNote2, 3, 4

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: iScape

Note 4: iBeam

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

510(k) NumberK091941
------------------------

Diagnostic Ultrasound Indications for Use Fe

0093

13

System Transducer × Model: 3C1 510(k) Number(s) Mode of Operation Clinical Application PW Color Amplitude Combined B M CWD Other (specify) D Doppler Doppler (specify) Ophthalmic Fetal P P P p P P Note 1, 2, 3 Abdominal P P P P P P Note 1, 2, 3 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric P P P P p P Note 1, 2, 3 Small organ(specify)** Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal Conventional Musculo-skeletal Superficial Intravascular Cardiac Adult P P P P P P Note 1, 2, 3 Cardiac Pediatric P P P P p P Note 1, 2, 3 Intravascular (Cardiac) Trans-esoph.(Cardiac) Intra-Cardiac Peripheral Vascular Other (specify)*** N=new indication; P=previously cleared by FDA; E=added under Appendix B 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: iScape Note 4: iBeam (Division Sign-Offy Division of Reproductive, Abdon

0094

Radiological Devices 510(k) Number

Diagnostic Ultrasound Indications for Use Form

14

Mindray Co. Ltd. - DC-3/DC

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SystemTransducerX
Model:2P2
510(k) Number(s)
Clinical ApplicationMode of Operation
BMPW
DCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPNote 1,
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPPNote 1,
Small organ(specify)**
Neonatal CephalicPPPPPPPNote 1,
Adult CephalicPPPPPPPNote 1,
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Intravascular
Cardiac AdultPPPPPPPNote 1, 2
Cardiac PediatricPPPPPPPNote 1, 2
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: iScape
Note 4: iBeam

Diagnostic III+

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15

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form

System
Model:7L5
510(k) Number(s)
TransducerX
BMPWDCWDColor DopplerAmplitude DopplerCombined (specify)Other (specify)
Clinical Application
Ophthalmic
Fetal
AbdominalPPPPPPNote 2, 3, 4
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 2, 3, 4
Small organ(specify)**PPPPPPNote 2, 3, 4
Neonatal CephalicPPPPPPNote 2, 3, 4
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal ConventionalPPPPPPNote 2, 3, 4
Musculo-skeletal SuperficialPPPPPPNote 2, 3, 4
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 2, 3, 4
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: iScape

Nofe 4: iBeam

Note 4: iBeam

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Kem

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

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0096

16

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

7LT4

Diagnostic Ultrasound Indications for Use Form

System Model: 51006 N

Transducer

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×

Mode of Operation
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPNote 2, 3, 4
Intraoperative (specify)*PPPPPPNote 2, 3, 4
Intraoperative (Neuro)
Laparoscopic
PediatricPPPPPPNote 2, 3, 4
Small organ(specify)**PPPPPPNote 2, 3, 4
Neonatal CephalicPPPPPPNote 2, 3, 4
Adult CephalicPPNote 2, 3, 4
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
ConventionalPPPPPPNote 2, 3, 4
Musculo-skeletal
SuperficialPPPPPPNote 2, 3, 4
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral VascularPPPPPPNote 2, 3, 4
Other (specify) ***
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
DopplerCombined
(specify)Other (specify)
Ophthalmic
FetalNNNNNNNote 1, 2
AbdominalNNNNNNNote 1, 2
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
PediatricNNNNNNNote 1, 2
Small organ(specify)**
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: iScape
Note 4: iBeam
Note 5: 4D
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

*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: iScape

Note 4: (Beam

Note 4. Beam

C

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

17

Diagnostic Ultrasound Indications for Use Form

Transducer

× ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

System Model: 510(k) Number(s)

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D6-2

098