M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
Device Facts
| Record ID | K172970 |
|---|---|
| Device Name | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 25, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) exams.
Device Story
Portable/mobile software-controlled diagnostic ultrasound system; acquires/displays images via linear, convex, and phased array probes. Operates in B, M, PW, CW, Color, Color M, Power/Dirpower, and TDI modes; supports combined modes (e.g., B/M). Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. Features include Contrast Imaging and Elastography. Output displayed on system monitor for clinician interpretation; aids in clinical decision-making for various anatomical exams. Benefits include non-invasive diagnostic visualization of internal structures and blood flow.
Clinical Evidence
Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2-2004 standards.
Technological Characteristics
Portable/mobile ultrasound system; uses linear, convex, and phased array transducers. Imaging modes: B, M, PW, CW, Color, Color M, Power/Dirpower, TDI. Materials consistent with predicate. Connectivity: standard ultrasound interface. Software-controlled. Sterilization: cleaning/disinfection per manufacturer instructions. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37.
Indications for Use
Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging and fluid flow analysis in gynecology, obstetrics, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, musculoskeletal (conventional/superficial), intraoperative, and transesophageal (cardiac) exams.
Regulatory Classification
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.
Predicate Devices
- M7 (K131690)
Reference Devices
- M9 (K171034)
Related Devices
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2, 2012
- K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Sep 12, 2017
- K200411 — Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 8, 2020
- K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Dec 13, 2017
- K172059 — LinkQuest Diagnostic Ultrasound System model SQ860 · Linkquest, Inc. · Oct 5, 2017
Submission Summary (Full Text)
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October 25, 2017
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Yang Zhaohui Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park. Nanshan, Shenzhen 518057 P. R. CHINA
## Re: K172970
Trade/Device Name: M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 15, 2017 Received: September 26, 2017
# Dear Yang Zhaohui:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'HaraFor
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
K172970
Device Name
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System
Indications for Use (Describe)
The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transvaginal, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) exams.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| | *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* |
| of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect |
| Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>PRAStaff(@fda.hhs.gov | Department of Health and Human Services |
| | "An agency may not conduct or sponsor, and a nerson is not required to respond to, a collection of |
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
EF
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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## Diagnostic Ultrasound Indications for Use Form
| System: | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System |
|---------------|-----------------------------------------------------------------------------------|
| Transducer: | N/A |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows |
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|----------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | P | P | P | P | P | P | Note 1,2,3,4,6,7 |
| | Abdominal | P | P | P | P | P | P | Note 1,2,3,4,5,6,7,9 |
| | Intraoperative (specify)* | P | P | P | P | P | P | Note1,2,4,6,7 |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1,2,3,4,5,6,7 |
| | Small organ(specify)** | P | P | P | P | P | P | Note 1,2,4,6,7,8 |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| | Adult Cephalic | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| | Trans-rectal | P | P | P | P | P | P | Note 1,2,4,6,7 |
| | Trans-vaginal | P | P | P | P | P | P | Note 1,2,4,6,7 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| | Musculo-skeletal Superficial | P | P | P | P | P | P | Note 1,2,4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1,2,5,6,7 |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1,2,5,6,7 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note1,2,5,6 |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | P | P | P | Note 1, 2, 4,6,7 |
| | Other (specify) | | | | | | | |
N=new indication; P=previously cleared by FDA(K131690, K171034); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
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M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:
C5-2s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | P | P | P | | P | P | Note 1, 2, 4,6,7,9 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| Vascular | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
Concurrence of CDRH, Office of Device Evaluation(ODE)
# Diagnostic Ultrasound Indications for Use Form
{5}------------------------------------------------
V10-4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Trans-vaginal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | |
| Vascular | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance; Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
### Diagnostic Ultrasound Indications for Use Form
{6}------------------------------------------------
V10-4Bs Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Trans-vaginal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
### Diagnostic Ultrasound Indications for Use Form
{7}------------------------------------------------
7L4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | Note 1,2, 4,6,7 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | 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 | Note 1,2, 4,6,7 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
{8}------------------------------------------------
L14-6s Transducer:
| Clinical Application | | Mode of Operation | | | | | | Other (specify) |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | Note 1,2, 4,6,7 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | 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 | Note 1,2, 4,6,7 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
{9}------------------------------------------------
P4-2s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| | Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6,7 |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
# Diagnostic Ultrasound Indications for Use Form
{10}------------------------------------------------
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:
P7-3s Transducer:
| Clinical Application | | Mode of Operation | | | | | | Other (specify) |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Adult Cephalic | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | Note 1, 2,5,6 |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2,5,6 |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
{11}------------------------------------------------
Transducer: 4CD4s
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | Note1,2, 3, 4,6 |
| | Abdominal | P | P | P | | P | P | Note1,2, 3, 4,6 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note1,2, 3, 4,6 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | |
| Vascular | Other (specify) | | | | | | | |
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
{12}------------------------------------------------
6C2s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Small organ(specify)** | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Adult Cephalic | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1, 2, 4,6,7 |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
# Diagnostic Ultrasound Indications for Use Form
{13}------------------------------------------------
7L5s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | Note 1,2, 4,6,7 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | P | | P | P | Note 1,2, 4,6,7 |
| Vascular | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
## Diagnostic Ultrasound Indications for Use Form
{14}------------------------------------------------
L7-3s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | Note 1,2, 4,6,7 |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | |
| | Other (specify)*** | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Other (specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA(K131690); 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.
**Small organ-breast, thyroid, testes.
***Other use includes urology.
Note 1: Tissue Harmonic Imaging;
Note 2: Smart3D;
Note 3:4D(Real-time 3D);
Note 4: iScape;
Note5: TDI;
Note6: Color M;
Note7: Biopsy Guidance;
Note8: Strain Elastography;
Note9: Contrast imaging (Liver Only)
#### Concurrence of CDRH, Office of Device Evaluation(ODE)
# Diagnostic Ultrasound Indications for Use Form
{15}------------------------------------------------
L12-4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|--------------------------------|-----------------------|-------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color/<br>Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1,2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | |
| | Intraoperative (Neuro) | | | | | |…
