DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

K101041 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · ITX · Apr 30, 2010 · Radiology

Device Facts

• Record ID: K101041
• Device Name: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: ITX · Radiology
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.

Device Story

DC-7 Diagnostic Ultrasound System is a portable, software-controlled, general-purpose ultrasound diagnostic system. It acquires and displays images in B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI mode, or combined modes (e.g., B/M). The system utilizes an array of probes (linear, convex, phased, volume) with a frequency range of 1.8 MHz to 12.0 MHz. Operated by clinicians in clinical settings, the device provides real-time imaging and measurements to assist in diagnostic exams. A unique feature is the calculation of the Ankle-Brachial Index (ABI). Healthcare providers use the displayed images and measurements to inform clinical decision-making. The device benefits patients by providing non-invasive diagnostic visualization of internal structures and vascular flow.

Clinical Evidence

Bench testing only. The device was tested as a Track 3 device per FDA guidance. Acoustic output was measured and calculated according to NEMA UD 2:2004 and NEMA UD 3:2004. Conformance to safety standards including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1 was demonstrated.

Technological Characteristics

Portable ultrasound system; frequency range 1.8-12.0 MHz. Probes: linear, convex, phased, volume arrays. Imaging modes: B, M, Color, Color M, PW, CW, Power/DirPower, TDI. Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1. Features include Tissue Harmonic Imaging, Smart3D, 4D, iScape, and ABI calculation.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for abdominal, cardiac, small organ (breast, testes, thyroid), peripheral vascular, fetal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (conventional and superficial), intraoperative, and transcranial ultrasound exams.

Regulatory Classification

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.

Predicate Devices

• Mindray DC-7 (K092691)
• Mindray DC-3 (K091941)
• GE Logiq PS (K060993)
• GE Voluson 730 (K041688)

Submission Summary (Full Text)

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# 510(K) SUMMARY

APR 3 0 2010

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:

### 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: [phone] Fax: [phone]

#### 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

Date Prepared: Jan. 08, 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 (90-1YN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

#### 3. Marketed Device:

DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688).

Compared to the original submission (K#092691), the technological characteristics are almost identical in this submission except for the new features and indications such as

B-1

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new probes, software functions, new algorithm and etc.

The only unique feature found on the DC-7 compared to the predicate devices is the calculation of the ABI(ankle-brachial index), this feature does not affect the safety or effectiveness of the device.

### 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, PW 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.

### 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, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.

### 6. Safety Considerations:

The DC-7 Diagnostic Ultrasound System had been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Sccking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD 3: 2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.

### Conclusion:

The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

JUN 3 - 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

Re: K101041 Trade/Device Name: DC-7 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II .. Product Code: IYN, ITX, and IYO Dated: April 13, 2010 Received: April 14, 2010

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of April 30, 2010.

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 Systems, as described in your premarket notification:

Transducer Model Number

| 3C5A | | | 7L5 |
|--------|--|--|-------|
| C5-2 | | | L12-4 |
| V10-4 | | | L7-3 |
| V10-4B | | | L11-4 |
| 6C2 | | | L14-6 |
| 7L4A | | | 2P2 |

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| <span style="text-decoration:underline">4CD4</span><br><span style="text-decoration:underline">P4-2</span><br><span style="text-decoration:underline">P7-3</span> | | <span style="text-decoration:underline">P12-4</span><br><span style="text-decoration:underline">7LT4</span><br><span style="text-decoration:underline">DE10-3</span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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/CDRH0ffices/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 vours.

Alberto S.

for: Donald St. Pierre
Acting Director

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(k) Number (if known):

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, elc.), peripheral vascular, fetal, transvaginal, pediatric, neonatal cephalic, musculoskeletal(conventional and superficial), intraoperative and transcranial exams.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Robert L. Becker
(Division Sign-Off)

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

510K K101041

Page 1 of

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

| System | X |
|------------------|------|
| Model: | DC-7 |
| 510(k) Number(s) | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|----------------------|
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1,2, 3, 4,7,8 |
| Abdominal | P | P | P | P | P | P | P | Note 1,2, 3, 4,5,7,8 |
| Intraoperative (specify)* | N | N | N | | N | N | N | Note 1,2,4,7,8 |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,5,7,8 |
| Small organ (specify) ** | P | P | P | | P | P | P | Note1 , 2, 4,7,8 |
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2, 4,5,7,8 |
| Adult Cephalic | P | P | P | P | P | P | P | Note1, 2. 4,5,7,8 |
| Trans-rectal | P | P | P | | P | () | P | Note 1,2,3,4,7,8 |
| Trans-vaginal | P | P | P | | P | P | P | Note 1,2,3,4,7,8 |
| Trans-urethral | | | | | | | | |
| Trans-esuph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P . | | P | p | P | Note 1,2,4,7,8 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2,4,7,8 |
| Intravascular | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,5,7,8 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,5,7,8 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | p | | P | P | P | Note 1,2,4,7,8 |
| 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.

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

Notc 2; Smart3D

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

Note 4: iScape

Note 5: TDI

Note6: Contrast Imaging

Note7: Color M

Note8: Biopsy Guidance

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

Concurrence of CDRH. Office of Revice Evaluation(ODE)

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Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

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Robert Becker
(Division Sign-Off)

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

510K K101041

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| System | | | | Transducer | | X | | |
|--------------------------------------------------------------------------------------------------|---|---|---------|------------|------------------|----------------------|-----------------------|------------------|
| Model: | | | 3C5A | | | | | |
| 510(k) Number(s) | | | K092691 | | | | | |
| | | | | | | | | |
| | | | | | | Mode of Operation | | |
| Clinical Application | B | M | PWD | CWI) | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Intraoperative (specify) * | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| 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. | | | | | | | | |
| 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: Contrast Imaging<br>Note7: Color M | | | | | | | | |
| Note8: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | |
| | | | | | | | | |

### Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

Robert Becker
(Division Sign Off)

Division of Radio Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101041

2

.

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

| Model: | | | C5-2 | | | | | | |
|------------------------------------------------------------------------------------------------------|-------------------|---|---------|-----|------------------|----------------------|-----------------------|------------------|--|
| 510(k) Number(s) | | | K092691 | | | | | | |
| | | | | | | | | | |
| | Mode of Operation | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| Intraoperative (specify) * | | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| Small organ(specify) * * | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| Musculo-skeletal Superficial | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-csoph.(Cardiac) | | | | | | | | | |
| Intra-Cardiac | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| 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. | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| Note 2: Smart3D | | | | | | | | | |
| Note 3:4D(Real-time 3D) | | | | | | | | | |
| Note 4: iScape<br>NoteS: TDI | | | | | | | | | |
| Note6: Contrast Imaging | | | | | | | | | |
| Note7: Color M | | | | | | | | | |
| Note8: Biopsy Guidance | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | Mode of Operation | | | | | | | | |
| Clinical Application | 13 | M | I'WD | CWD | Color | Amplitude | Combined | Other (specify) | |
| | | | | | Doppler | Doppler | (specify) | | |
| Ophthalmic | | | | | | P | P | Note 1. 2. 4,7,8 | |
| Fetal | P | p | 11 | | P | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative (specify) * | | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small organ(specify) * · | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 | |
| Trans-vaginal | P | P | P | | p | P | P | Note 1, 2, 4,7,8 | |
| 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; Papreviously 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. | | | | | | | | | |
| ** Small organ-breast, thyroid, testes, etc. | | | | | | | | | |
| 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: Contrast Imaging | | | | | | | | | |
| Note7: Color M | | | | | | | | | |
| Note8: Biopsy Guidance | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | |

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(Division Sign/DII)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluatiory and Safety

510K K101041

(Division Sign-Off)

Prescription USE (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use FormTransducer

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Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Device Office of In Vitro Diagnostic Device Evalyation and Salety

510K K101041

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| Model: | V10-4B | | | | | | | |
|----------------------------------------------------------------------------------------------------|---------|---|-----|-----|------------------|----------------------|-----------------------|------------------|
| 510(k) Number(s) | K092691 | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Trans-vaginal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| 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. | | | | | | | | |
| **Small organ-breast, thyroid, testes, etc. | | | | | | | | |
| 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: Contrast Imaging | | | | | | | | |
| Note7: Color M | | | | | | | | |
| Note8: Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |

Diagnostic Ultrasound Indications for Use Form

Transducer

x

Prescription USE (Per.21 CFR 801.109)

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

510K K101041

5

: 上一篇:

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

x

System Modcl:

510(k) Number(s)

| | Transducer |
|----------|------------|
| 6C2 | |
| King2017 | |

| Clinical Application | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Adult Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-csoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1, 2, 4,7,8 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1; 2, 4,7,8 |
| 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. | | | | | | | | |
| 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: Contrast Imaging | | | | | | | | |
| Note7: Color M | | | | | | | | |
| Note8: 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 CER 801.109)

Robert Becker
(Division Sign-Off)

510K

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

റ

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

Transducer System × 7L4A Model: Kugayaan うけの(k) Number(s) Mode of Operation Clinical Application Color Amplitude Combined PWD CWD છ M Other (specify) Dopples Doppicr (spccify) Ophthalmic どこはし Ahdominal P P . P P P P Note 1.2. 4.7,8 Intraoperative (specify) lutraoperative (Neuro) l.aparoscopic l'ediatric p p P P p P Note 1.2. 4.7.8 Sinall organ(specify)" " ין P P P P P Note 1,2, 4,7,8 Noonatal Cophalic P P P P P P Note 1.2. 4.7,8 Adult Cophalic 『rans-rectat Trans-vaginal Trans-urethral Trans-csoph. (non-Card.) Musculo-skeletal Conventional P P P P P P Nosc 1,2, 4,7,8 Musculo-skelctal Superficial p p p p P P Note 1,2, 4,7,8 Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-csoph.(Cardiac) Intra-Cardiac Peripheral Vascular P P P P P P Note t,2, 4,7,8 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. Note I : Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Sman3D Note 3: 4D(Real-time 3D) Note 4: iScape NoteS : TDI Note6 : Contrast Imaging Note7: Color M Note8 : 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)

Robert Beecher

Division of Radiotogical D stic Device Evaluation and Safety Office of In

610K K101041

Diagnostic Ultrasound Indications for Use Form

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

| System | | | | Transducer | | X | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|---------|------------|------------------|----------------------|-----------------------|-----------------|
| Model: | | | 7L5 | | | | | |
| 510(k) Number(s) | | | K092011 | | | | | |
| | | | | | | | | |
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| 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. | | | | | | | | |
| 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 : Contrast Imaging<br>Note7 : Color M | | | | | | | | |
| Note8 : Biopsy Guidance | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | |

. . . .

Prescription USE (Per 21 CFR 801.109)

10K

.

.

.

Robert R. Rockey
(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Disgnastio Device Evely ation and Sefety

8

. ﺍ

. . .

.

, :

.

.

. . ·

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

System Model:

#### Transducct × LI2-4 . Колдыя:

510(k) Number(s)

| 510(k) Number(s) | | | | | | | | |
|-----------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| | Mode of Operation | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | Note 1,2,4,7,8 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | Note 1.2, 4,7,8 |
| Small organ(specify)** | P | P | P | | P | P | P | Note 1.2. 4.7.8 |
| Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | |…