(140 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound images," which indicates a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components essential for ultrasound imaging.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text clearly describes a Diagnostic Ultrasound System. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
- Intended Use: The intended use lists various anatomical sites and patient populations for imaging, which is consistent with an ultrasound system, not an IVD.
Therefore, based on the provided information, the M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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, 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.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
Product codes
IYN, IYO, ITX
Device Description
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-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, convex array and phased array.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, Intra-operative, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, urology.
Indicated Patient Age Range
adults, pregnant women, pediatric patients, and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131690, K102991, K163690, K170277, K152543
Reference Device(s)
K102991, K163690, K170277, K152543
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | ✔ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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EF
attachment 2-1
3
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 | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (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 & | |||||||||
| 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 | |||||||||
| (Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 | |
| Musculo-skeletal | |||||||||
| (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 | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (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 & | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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 | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (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 & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & 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 | |||||||||
| Conventional | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| Superficial | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| 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 | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (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 & | ||||||||||
| 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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (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 | ||||||||||
| 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 | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (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 | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (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 | ||||||||||
| & 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 | ||||||||||
| 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 | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| General | |||||||||
| (Track 1 Only) | (Track 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & 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 | |||||||||
| Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Cardiac | Intravascular | ||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & 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 | |||||||||
| Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral Vascular | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Peripheral | |||||||||
| 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 | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| 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 | |||||||||
| (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| 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 | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & 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 | |||||||||
| Conventional | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| Superficial | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| 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 | |||||||||
| 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 | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| General (Track | |||||||||
| 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 & | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| 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 | ||||
| Intraoperative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | P | b | P | b | P | P | Note1,2,4,6,7 | ||||
| Small organ(specify)** | P | b | P | P | P | P | Note1,2,4,6,7 | ||||
| Fetal | |||||||||||
| Imaging | |||||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | Note1,2,4,6,7 | |||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph.(non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | b | P | b | P | P | Note1,2,4,6,7 | ||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | P | Note1,2,4,6,7 | ||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-Cardiac | |||||||||||
| Peripheral | Peripheral Vascular | P | b | P | b | P | P | Note1,2,4,6,7 | |||
| 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)
16
L16-4Hs Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | Note1,2,4,6 | ||
| Intra-operative (Specify*) | P | P | P | P | P | P | Note1,2,4,6 | ||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note1,2,4,6 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note1,2,4,6 | ||
| Neonatal Cephalic | P | P | P | P | P | P | Note1,2,4,6 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | P | Note1,2,4,6 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | Note1,2,4,6 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | Note1,2,4,6 | |
| 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(K170277, 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)
17
P4-2s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| 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(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)
18
2P2s Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (Specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | ||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | ||
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | |
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 | ||
| 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(K102991, 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)
19
P7-3s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6 |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral 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(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)
20
P12-4s Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | Note 1,2,4,5,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6 | ||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 | ||
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,4,5,6 | |
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6 | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6 | ||
| 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(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)
21
V10-4s Transducer:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||||
| (Track 1 Only) | Specific | ||||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Combined | ||||||||||
| (specify) | Other (specify) | ||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Abdominal | |||||||||||
| Intraoperative (specify)* | |||||||||||
| Intraoperative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small organ(specify)** | |||||||||||
| Fetal | Neonatal Cephalic | ||||||||||
| Imaging | Adult Cephalic | ||||||||||
| & Other | Trans-rectal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Trans-vaginal | P | P | P | P | b | b | Note 1, 2, 4,6,7 | ||||
| Trans-urethral | |||||||||||
| Trans-esoph.(non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-Cardiac | |||||||||||
| Peripheral | Peripheral Vascular | P | |||||||||
| Vascular | Other (specify)*** | b | P | P | b | b | b | 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(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)
22
V10-4Bs Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Abdominal | |||||||||
| Intraoperative (specify)* | |||||||||
| Intraoperative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ(specify)** | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| 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 | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Peripheral | |||||||||
| Vascular | Peripheral Vascular | ||||||||
| Other (specify)*** | 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(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)
23
6CV1s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1,2,4,6,7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | ||||||||
| 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) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | 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(K102991, 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)
24
6LB7s Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General (Track | ||||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (Specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | P | P | P | P | P | P | Note 2,4,6,7 | ||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| vessel | Other (Specify***) | P | P | P | P | P | P | Note 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(K102991, 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)
25
4CD4s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1,3,4,6 | ||
| Abdominal | P | P | P | P | P | P | Note 1,3,4,6 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,3,4,6 | ||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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(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)
26
D7-2s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 3, 4, 6 | ||
| Abdominal | P | P | P | P | P | P | Note 1, 3, 4, 6 | ||
| Fetal Imaging & | |||||||||
| Other | Intra-operative (Specify*) | ||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral 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 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)
27
CW2s 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 | ||||||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | |||||||||
| Small organ(specify)** | ||||||||||
| Fetal | Neonatal Cephalic | |||||||||
| Imaging | Adult Cephalic | P | ||||||||
| & Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | |||||||||
| Cardiac Pediatric | P | |||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| Peripheral | Peripheral Vascular | |||||||||
| 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)
28
CW5s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| General (Track | |||||||||
| 1 Only) | Ophthalmic | ||||||||
| Ophthalmic | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic | P | |||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P | ||||||||
| Cardiac Pediatric | P | ||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral 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(K170277); 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)
29
DE11-3s Transducer:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General (Track | |||||||||
| 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Abdominal | |||||||||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | |
| Trans-vaginal | P | P | P | P | P | P | Note 1, 3, 4, 6, 7 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (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(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)
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P7-3Ts Transducer:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| (Track 1 Only) | (Track 1 & 3) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small organ(specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | P | P | P | P | P | P | P | Note1,2,5,6 | ||
| Intra-Cardiac | ||||||||||
| Peripheral | ||||||||||
| Vascular | Peripheral 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)
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
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: +86 755 8188 5640 Fax: +86 755 2658 2680
Contact Person:
Yang Zhaohui Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: May 19, 2017
- Device Name: M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Device Description:
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-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, convex array and phased array.
B-1
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4. 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.
5. Comparison with Predicate Devices:
| Predicate Device | Manufacturer | Model | 510(k) Number |
|---|---|---|---|
| 1.Primary predicate | |||
| device | Mindray | M7 | K131690 |
| 2.Reference device | Mindray | M5 | K102991 |
| 3.Reference device | Mindray | DC-70 | K163690 |
| 4.Reference device | Mindray | DC-8 | K170277 |
| 5.Reference device | Mindray | M9 | K152543 |
M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.
The materials of probes and Needle-guided brackets of M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 are the same to the probe of predicate device.
The acoustic power levels of M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 are below the limits of FDA, which are the same as the predicated device M7(K131690). The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 has the same imaging modes as the predicated devices.
All of the functions of M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 are the same as the predicated devices.
The M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 have similar tranducers with the predicated devices.
6. Non-clinical Tests:
M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness
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as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle processes.
- ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
- NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- . AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices part 1: evaluation and testing within a risk management process.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.