(52 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes.
No
The device is described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound images", indicating its use for diagnosis, not therapy.
Yes
The document explicitly states in its title and first sentence, "The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System" and "DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic 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 acquiring ultrasound images.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device description: The provided text 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 clearly states it's for various types of ultrasound exams on different parts of the body and patient populations. This involves imaging, not analyzing biological samples.
Therefore, based on the provided information, the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, 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, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, breast, thyroid, testes, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology, transesophageal (Cardiac)
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 were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards. Clinical tests were Not Applicable. The device was found substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150080, K162267, K160807, K153529, K152543, K131690
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing, ribbon-like design connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Yang Zhaohui Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan, Shenzhen 518057 P.R. CHINA
CHINA
Re: K170277
Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: January 16, 2017 Received: January 30, 2017
Dear Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,
Michael D.'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
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
Indications for Use (Describe)
The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Diagnostic Ultrasound Indications For Use Format
| System: | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||||
| 510(k) Number: | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| 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, 2,3, 4,6,7 | ||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7,9 | |
| Intra-operative (Specify*) | P | P | P | P | P | P | Note 1, 2, 4 | ||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,3, 4,6,7 | |
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | ||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| Trans-rectal | P | P | P | P | P | P | Note 1, 2,3, 4,6,7 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1, 2,3, 4,6,7,8 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | 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 | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7,10 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1, 5,6 | |
| 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 | 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、Power + 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 | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| Note 8: Elastography | |||||||||
| Note 9: Contrast imaging - liver only | |||||||||
| Note10: Contrast imaging - LVO only |
4
System: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Transducer: C5-2E
510(k) Number:
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 | 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 | |||
| Fetal Imaging & | ||||||||||
| Other | 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 | ||||||||||
| 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) | ||||||||||
| Cardiac | Intravascular | |||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Peripheral vessel | Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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**) | ||||||||||
| Fetal Imaging & | Neonatal Cephalic | |||||||||
| 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 vessel | Peripheral vessel | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging — LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |||
| Fetal Imaging & | ||||||||||
| Other | 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) | 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***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4,6,7,8 | |||
| Fetal Imaging & | ||||||||||
| Other | 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) | 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 | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Peripheral vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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 | 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) | 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 vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | |||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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, 2,4,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| Adult Cephalic | P | 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) | ||||||||||
| 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 vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | Note1,3, 4,6,7 | |||
| Abdominal | P | P | P | P | P | P | Note1,3, 4,6,7 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note1,3,4,6,7 | |||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | Neonatal Cephalic | |||||||||
| 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 vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***()ther use includes Urology. | ||||||||||
| Note 2: Smart3D | Note 1: Tissue Harmonic Imaging. | |||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note5: TDI | Note 4: iScape | |||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH Office of Device Evaluation(ODE) | ||||||||||
| 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, 3, 4,6 | |||
| Abdominal | P | P | P | P | P | P | Note1, 3, 4,6 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note1,3, 4,6 | |||
| 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 | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | 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 | ||||||||||
| 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, 4,6,7,8 | |||
| Cardiac | Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | Peripheral vessel | |||||||||
| Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) |
5
System: Transducer:
510(k) Number:
C7-3E
Intended Use:
6
Transducer:
L12-3E
510(k) Number:
7
System: Transducer:
510(k) Number:
L14-6NE
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
Concurrence of CDRH, Office of Device Evaluation(ODE)
8
Transducer:
System:
510(k) Number:
L14-6WE
9
System: Transducer:
510(k) Number:
P4-2E
Intended Use:
10
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: Transducer: D6-2E 510(k) Number: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
11
| System: | DC-8/D |
|---|---|
| Transducer: | D8-3E |
| 510(k) Number: | |
| Intended Use: | Diagnos |
12
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: V11-3E Transducer: 510(k) Number: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
13
Transducer: C11-3E
510(k) Number:
| 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 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**) | ||||||||||
| 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 | Cardiac Adult | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| 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***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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 | 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 | ||||||||||
| Adult Cephalic | ||||||||||
| 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 vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | 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 | ||||||||||
| 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, 4,6,7,8 | |||
| 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 | ||||||||||
| Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Peripheral vessel | N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B. | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| ** 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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging – liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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**) | ||||||||||
| 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, 4,6,7,8 | |||
| 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 | |||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M, PW+B, Color + B, Power+B, PW+Color+B, Power + PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| ** 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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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 | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | 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 | |||
| 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) | 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 vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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, 2,4,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,6 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | ||
| 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 vessel | ||||||||||
| Peripheral vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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**) | ||||||||||
| 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) | P | P | P | P | P | P | P | Note 1, 5,6 | ||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Peripheral vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | |||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | |||||||||
| Cardiac Pediatric | P | |||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | Peripheral vessel | P | ||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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 | P | |||||||||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | Neonatal Cephalic | |||||||||
| 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***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| ** 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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging – LVO only | ||||||||||
| 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, 2,4,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,6 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | |
| Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6 | ||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | Note 1, 2,4,6 | ||
| 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 vessel | ||||||||||
| Peripheral vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| ** Small organ-breast, thyroid, testes, | ||||||||||
| ***()ther use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. . | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3: 4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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, 2,4,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | P | 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) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7,10 | ||
| 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 vessel | ||||||||||
| Peripheral vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| 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**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | P | Note 1, 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 vessel | ||||||||||
| Peripheral vessel | Other (Specify***) | P | P | P | P | P | P | Note 1, 2, 4,6,7 | ||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+ B、Power + PW +B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | ||||||||||
| **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 | ||||||||||
| Note 5: TDI | ||||||||||
| Note 6: Color M | ||||||||||
| Note 7: Biopsy Guidance | ||||||||||
| Note 8: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | P | Note 1, 2,4, 6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2,4, 6,7 | ||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | 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) | ||||||||||
| Musculo-skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7,10 | |
| Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7 | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); | E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power+PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| ** 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: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging – LVO only | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| 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 | ||
| Abdominal | P | P | P | P | P | P | P | Note 1, 2, 4,6 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | Note 1, 2, 4,6 | ||
| Small Organ (Specify**) | ||||||||||
| Fetal Imaging & | ||||||||||
| Other | Neonatal Cephalic | |||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P | P | Note 1, 2, 4,6 | ||
| 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 | |
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K150080); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power+PW+B. | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **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: Elastography | ||||||||||
| Note 9: Contrast imaging - liver only | ||||||||||
| Note10: Contrast imaging - LVO only | ||||||||||
| DDIT OW |
14
Transducer: DE10-3E
510(k) Number:
15
Transducer: V11-3BE
510(k) Number:
16
Transducer: V11-3WE
510(k) Number:
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
010-15
17
Transducer: L7-3E
510(k) Number:
18
Transducer: P10-4E
510(k) Number:
19
P7-3TE Transducer:
510(k) Number:
20
Transducer: CW2s
510(k) Number:
21
Transducer: CW5s
510(k) Number:
22
Transducer: P7-3E
510(k) Number:
23
P4-2NE Transducer:
510(k) Number:
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
010-22
24
Transducer: CB10-4E
510(k) Number:
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
25
Transducer: SP5-1E
510(k) Number:
26
Transducer: SC5-1E
510(k) Number:
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
Concurrence of CDRH, Office of Device Evaluation(ODE)
27
Transducer: L10-3E
510(k) Number:
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 | |||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2,4 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2,4 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2,4 | ||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2,4 | |
| 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 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2,4 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | Note 1,2,4 | ||
| Peripheral vessel | Other (Specify***) | ||||||||
| 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 | ||
| Intra-operative (Specify*) | P | P | P | P | P | P | Note 1,2, 4 | ||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2, 4 | ||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2, 4 | ||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1,2, 4 | |
| 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 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | Note 1,2, 4 | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | Note 1,2, 4 | ||
| Peripheral vessel | Other (Specify***) | ||||||||
| N=new indication; P=previously cleared by FDA(K131690,K150080); E=added under Appendix E | |||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B. | |||||||||
| *Intraoperative includes abdominal, thoracic, and vascular. | |||||||||
| **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 | |||||||||
| Note 5: TDI | |||||||||
| Note 6: Color M | |||||||||
| Note 7: Biopsy Guidance | |||||||||
| Note 8: Elastography | |||||||||
| Note 9: Contrast imaging - liver only | |||||||||
| Note10: Contrast imaging - LVO only |
28
Transducer: L16-4HE
510(k) Number:
29
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.
The assigned 510(k) number is:
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +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
January 16, 2017 Date Prepared:
2. Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic
Ultrasound System
Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
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30
21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
3. Device Description:
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, 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, 3D/4D mode, Elastography or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.
4. Intended Use:
The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.
5. Summary of Modifications and Newly Added Features
This submission device is a modification to DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System previously cleared in K150080.
The following is a brief overview of the modifications and newly added features.
- Newly added transducers .
L16-4HE
L10-3E
- . Newly added software options
Smart MSP
Smart FLC
- Add the Contrast Imaging Function to C7-3E and C5-2E I
31
All of the above modifications and newly added features have been compared with the predicate devices. The results show that these modifications and newly added features are substantially equivalent to the predicate devices.
6. Comparison with Predicate Devices:
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k)
Number |
|---------------------|--------------------------------|----------|------------------|
| 1 | Mindray | DC-8 | K150080 |
| 2 | Mindray | Resona 7 | K162267 |
| 3 | Philips | EPIQ 5 | K160807 |
| 4 | SAMSUNG
MEDISON
CO., LTD | WS80A | K153529 |
| 5 | Mindray | M9 | K152543 |
| 6 | Mindray | M7 | K131690 |
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices.
- Subject device DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S has the same intended . uses as the predicated device DC-8(K150080)
| Items | Subject Device | Predicate device |
|---|---|---|
| DC-8/DC-8 PRO/DC-8 CV/DC-8 | ||
| EXP/DC-8S | DC-8 (K150080) | |
| Intended use | The DC-8/DC-8 PRO/DC-8 CV/DC-8 | |
| EXP/DC-8S diagnostic ultrasound | ||
| system is applicable for adults, | The DC-8/DC-8 PRO/DC-8 CV/DC-8 | |
| EXP/DC-8S diagnostic ultrasound | ||
| system is applicable for adults, pregnant |
32
| pregnant women, pediatric patients and
neonates. It is intended for use in fetal,
abdominal, pediatric, small organ
(breast, thyroid, testes), neonatal
cephalic, adult cephalic, trans-rectal,
trans-vaginal, musculo-skeletal
(conventional, superficial), cardiac
adult, cardiac pediatric, peripheral
vessel, urology and transesophageal
(Cardiac) exams. | women, pediatric patients and neonates.
It is intended for use in fetal,
abdominal, pediatric, small organ
(breast, thyroid, testes), neonatal
cephalic, adult cephalic, trans-rectal,
trans-vaginal, musculo-skeletal
(conventional, superficial), cardiac
adult, cardiac pediatric, peripheral
vessel, urology and transesophageal
(Cardiac) exams. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
- I The patient contact material of the L10-3E and L16-4HE are tested under ISO 10993-1.
- . The acoustic power levels of DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S are below the limits of FDA, which is the same as the predicated device DC-8(K150080).
- . DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-8(K150080).
- . The newly added features: Smart MSP, Smart FLC, Contrast Imaging Function are identical as the predicated devices.
- . The newly added transducers L16-4HE and L10-3E are also compared with the predicate devices.
7. Non-clinical Tests:
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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.
Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
- AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General
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33
requirements for basic safety and essential performance
- . AAMI/ANSI/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- . IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . IEC 62304: Medical device software - Software life cycle processes
- IEC 62366: Medical devices Application of usability engineering to medical I devices
- . IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability
- l ISO14971: Medical devices - Application of risk management to medical devices
- . UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
8. Clinical Tests:
Not Applicable.
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 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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