M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
Device Facts
| Record ID | K171579 |
|---|---|
| Device Name | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 18, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, Trans-esoph. (Cardiac), peripheral vessel and urology exams.
Device Story
Portable/mobile diagnostic ultrasound system; acquires/displays images in B, M, PW, CW, Color, Color M, Power/Dirpower, and TDI modes. Uses linear, convex, and phased array probes. Operated by clinicians in clinical settings. System processes acoustic signals to produce real-time images for diagnostic visualization and fluid flow analysis. Output assists clinicians in patient assessment and clinical decision-making across various anatomical regions. Benefits include non-invasive diagnostic imaging for diverse patient populations.
Clinical Evidence
Bench testing only. Evidence includes acoustic output measurements, biocompatibility testing, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing per IEC/AAMI/ANSI standards (e.g., IEC 60601-1, IEC 60601-2-37, NEMA UD 2). No clinical data presented.
Technological Characteristics
Portable/mobile ultrasound system; linear, convex, and phased array transducers. Modes: B, M, PW, CW, Color, Color M, Power/Dirpower, TDI. Materials: biocompatible probe and needle-guide materials. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993-1. Software: AAMI/ANSI/IEC 62304 compliant.
Indications for Use
Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional/superficial), cardiac (adult/pediatric/trans-esophageal), peripheral vessel, and urology 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
- M5 (K102991)
- DC-70 (K163690)
- DC-8 (K170277)
- M9 (K152543)
Related Devices
- K100830 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 5, 2010
- K123503 — DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 13, 2012
- K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 6, 2006
- K172970 — M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 25, 2017
- 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
Submission Summary (Full Text)
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October 18, 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 Guangdong P.R. CHINA
## Re: K171579
Trade/Device Name: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 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 8, 2017 Received: September 12, 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.
{1}------------------------------------------------
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'Hara For
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K171579
Device Name
M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
Indications for Use (Describe)
The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-rectal, trans-vaginal, musculo-skeletal (conventional),
musculo-skeletal (superficial), cardiac pediatric, Trans-esoph.(Cardiac), peripheral vessel and urology exams.
| Type of Use (Select one or both, as applicable) | <span> ✔ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
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EF
attachment 2-1
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#### Diagnostic Ultrasound Indications For Use Format
System: M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System
Transducer:
1
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | N | N | N | N | Note 1, 2,3,4,6,7 |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2,3,4,5,6,7,9 |
| | Intra-operative (Specify*) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| | Intra-operative (Neuro) | | | | | | | | |
| Fetal Imaging &<br>Other | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2,3, 4,5,6,7 |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7,8 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1, 2, 3,4,6,7 |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2, 3,4,6,7 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,4,5,6,7 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1,2,5,6 |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
| vessel | Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、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)
{4}------------------------------------------------
C5-2s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| vessel | Other (Specify***) | | | | | | | | |
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K163690); 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)
{5}------------------------------------------------
3C5s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | Note 1,2,4,6,7 |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2,4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,4,6,7 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1,2,4,6,7 |
| | Other (Specify***) | P | P | P | P | P | P | P | Note 1.2.4.6.7 |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K163690, K102991); 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)
{6}------------------------------------------------
6C2s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | Other (specify) |
|-----------------------------|----------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small organ(specify)** | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Adult Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Other (specify)*** | | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
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)
{7}------------------------------------------------
C11-3s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|--|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,4,6,7 | |
| Fetal Imaging &<br>Other | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,4,6,7 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,4,6,7 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,4,6,7 | |
| | Other (Specify***) | | | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K152543, 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 etc.
**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)
{8}------------------------------------------------
C6-2Gs Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note1,2,4,6,7 |
| | Abdominal | P | P | P | | P | P | P | Note1,2,4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note1,2,4,6,7 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | | |
| Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| vessel | Other (Specify***) | | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K152543, 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)
{9}------------------------------------------------
7L4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------|---------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|--|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| (Track 1 Only) | (Track 1 & 3) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Intraoperative (specify)* | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| Fetal | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | | |
| | Musculo-skeletal | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Conventional | | | | | | | | | |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 | |
| Vascular | Other (specify)*** | | | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
|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)
{10}------------------------------------------------
L7-3s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|----------------------------------|---------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| | Specific | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| General<br>(Track 1 Only) | (Track 1 & 3) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| Cardiac | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P |
| | | Other (specify)*** | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
|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)
{11}------------------------------------------------
7L5s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|----------------------------------|--------------------|---|-----|-----|------------------|----------------------------------------------------------------------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Peripheral<br>Vascular | Other (specify)*** | | | | | | | |
| | | | | | | | N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
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)
{12}------------------------------------------------
L12-4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Other (Specify***) | | | | | | | | |
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K152543, 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)
{13}------------------------------------------------
L14-6s Transducer:
| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|----------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Small organ(specify)** | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Adult Cephalic | | | | | | | | |
| & Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Other (specify)*** | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
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)
{14}------------------------------------------------
L14-6Ns Transducer:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| General (Track<br>1 Only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1, 2, 4,6,7,8 |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Other (Specify***) | | | | | | | | |
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N=new indication; P=previously cleared by FDA(K152543, 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)
{15}------------------------------------------------
7LT4s Transducer:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|----------------------------------|-------------------|---|-----|-----|---------|-----------|-----------|-----------------|--|--|
| General | Specific | B | M | PWD | CWD | Color | Amplitude | Combined | Other (specify) | | |
| (Track 1 Only) | (Track 1 & 3) | | | | | Doppler | Doppler | (specify) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | | | | | | | | | |
| | Abdominal | b | b | P | | P | P | P | Note1,2,4,6,7 | | |
| | Intraoperative (specify)* | P | P | P | | P | P | P | Note1,2,4,6,7 | | |
|…
