(87 days)
Not Found
No
The summary describes a general-purpose ultrasound system with software control and "zone technology" for image quality optimization. There is no mention of AI, ML, or related terms in the device description, intended use, or performance studies summary. The "exam dependent default settings" and "in depth soft-menu control" suggest traditional software logic rather than AI/ML-driven adaptation.
No
The documentation states the device is intended for "ultrasound evaluation" and describes it as a "diagnostic ultrasound system," indicating its purpose is for diagnosis, not therapy.
Yes
The "Device Description" explicitly states, "The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions features like a "multi-transducer port" and operation on "battery or AC power," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "ultrasound evaluation" of various anatomical sites. This involves using ultrasound technology to visualize internal structures of the body.
- Device Description: The description confirms it's a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data."
- Nature of IVDs: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside the body.
This device is clearly an in vivo diagnostic imaging system, meaning it is used to diagnose conditions by examining the body directly.
N/A
Intended Use / Indications for Use
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/Transcrania; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superticial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality. The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal (renal, GYN/Pelvic), Intra-operative (abdominal, thoracic(cardiac), and vascular), Intraoperative (Neuro), Pediatric, Small organ (thyroid, breast, testes, etc), Neonatal cephalic, Adult Cephalic/Transcranial, Trans-rectal, Trans-vaginal, Trans-esoph.(non-Card), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician
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, as well as thermal, electrical, and mechanical safety. The device was found to conform with applicable medical safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO14971, UD 2, UD 3, and ISO 10993-1. Clinical tests are Not Applicable.
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.
K151175, K170277, K160184, K163077, K152543
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 U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
September 21, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Mindray Bio-Medical Electronics Co., Ltd % Mr. Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057, Guangdong CHINA
Re: K171891
Trade/Device Name: ZS3 and z.one Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 15, 2017 Received: August 21, 2017
Dear Mr. Pei:
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 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 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. 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
Indications for Use
510(k) Number (if known)
K171891
Device Name ZS3 and z.one pro Ultrasound Systems
Indications for Use (Describe)
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/Transcrania; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superticial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| System: | ZS3, z.one pro Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | System union of all transducer types | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal Imaging | |||||||||
| & Other | Fetal | P | P | P | P | P | P | P5, P9 | |
| Abdominal6 | P | P | P | P | P | P | P5, P9, N11, N12 | ||
| Intra-operative (Specify)7 | P | P | P | P | P | P5 | |||
| Intra-operative (Neuro) | P | P | P | P | P | P5 | |||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P5, P9 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | P | P | P | P | P | P5, P8 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P5 | ||
| & Other | Adult Cephalic/Transcranial | P | P | P | P | P | P | P5 | |
| Trans-rectal | P | P | P | P | P | P5, P9 | |||
| Trans-vaginal | P | P | P | P | P | P5, P9 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | P | P | P5 | ||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P5, P8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P5, P8 | ||||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | P1 | P | P | P | P | P | P5, P10 | |
| Cardiac Pediatric | P | P | P | P | P | P | P5, N10 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, N10 | ||
| Intra-cardiac | P | P | P | P | P | P | N10 | ||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | P5, P8, P9 | |
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | 6 Abdominal includes renal, GYN/Pelvic | ||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| Mode of Operation | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Curvillinear Transducer C4-1 | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | |||||||||
| General(Track | |||||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | PWD | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal6 | P | P | P | P | P | P | N11, N12 | ||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | ||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | |||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P1 | P | P | P | P | P | P10 | ||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| Mode of Operation | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Curvillinear Transducer C6-2 | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | |||||||||
| General(Track | |||||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | PWD | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Pediatric | P | P | P | P | P | P5 | ||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | P5 | |||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| B | M | PWD | |||||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Curvillinear Transducer C9-3 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7.1, 7.3 | P | P | P | P | P | p5 | |||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| 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 | p5 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | p5 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | p5 | ||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Convex Transducer C10-3 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | CWD | P | P | ||
| Fetal | P | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | P | P5, N11 | ||
| Intra-operative (Specify)7 | P | P | P | P | P | P | p5 | ||
| Intra-operative (Neuro) | P | P | P | P | P | P | p5 | ||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | p5 | ||
| Fetal Imaging | Small Organ (Thyroid, Breast, | ||||||||
| Testes, etc.) | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | p5 | |
| Adult Cephalic/Transcranial | P | P | P | P | P | P | p5 | ||
| 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 | P5, N10 | ||
| Cardiac Pediatric | P | P | P | P | P | P | P5, N10 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | p5 | |
| vessel | Other(Specify) | ||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| Mode of Operation | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Curvillinear Transducer C8-3 3D | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | |||||||||
| General(Track | |||||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | PWD | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P5, P9 | |||
| Abdominal6 | P | P | P | P | P | P5, P9, N11 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P5, P9 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P5, P9 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Phased (Sector) Array Transducer P4-1c | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | P | P | P | P | P | P | p5 | |
| Abdominal6 | P | P | P | P | P | P | P5, N11 | ||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | p5 | ||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | p5 | ||
| Adult Cephalic/Transcranial | P | P | P | P | P | P | p5 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Cardiac | Intravascular | ||||||||
| Cardiac Adult | P1 | P | P | P | P | P | p5, p10 | ||
| Cardiac Pediatric | P | P | P | P | P | P | p5 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P | p5 | |
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 12 ARFI | 11 CEUS (Contrast agent for Liver) | ||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Endo-Cavity Transducer E9-3 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal® | |||||||||
| Intra-operative (Specify)' | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Fetal Imaging | Testes, etc.) | ||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | p5 | |||
| Trans-vaginal | P | P | P | P | P | p5 | |||
| 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 | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other (Specify) | ||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| Mode of Operation | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Endo-Cavity Transducer E9-4 | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | |||||||||
| B | M | PWD | |||||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| General(Track | |||||||||
| 1 Only) | Specific(Track 1 & 3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | p5 | |||
| Trans-vaginal | P | P | P | P | P | p5 | |||
| 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 | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, PD, PD, PD, | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Endo-Cavity Transducer E9-3 3D | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | ps, pº | |||
| Abdominal6 | |||||||||
| Intra-operative (Specify)' | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Fetal Imaging | Testes, etc.) | ||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | ps, p9 | |||
| Trans-vaginal | P | P | P | P | P | ps, p9 | |||
| 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 | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| vessel | Other(Specify) | ||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Linear Transducer L10-5 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | P | P | P5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | P | P | P | P | P | P5 | |||
| Intra-operative (Neuro) | P | P | P | P | P5 | ||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | P | P | P | P | P | P5, P8 | |||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P5 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P5, P8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P5, P8 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P5, P8 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Linear Transducer L8-3 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | P | P | P | P | P | P5 | |||
| Intra-operative (Neuro) | P | P | P | P | P | P5 | |||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P5 | |||
| Fetal Imaging | |||||||||
| & Other | Small Organ (Thyroid, Breast, | ||||||||
| Testes, etc.) | P | P | P | P | P | P5, P8 | |||
| Neonatal Cephalic | P | P | P | P | P | P5 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P5, P8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P5, P8 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | P5, P8 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 12 ARFI | 11 CEUS (Contrast agent for Liver) | ||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Linear Transducer L14-5sp | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | P | P | P | P | P | p5 | |||
| Intra-operative (Neuro) | P | P | P | P | p5 | ||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | P | P | P | P | P | p5, p8 | |||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | p5 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | p5, p8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | p5, p8 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | p5, p8 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Linear Transducer L14-5w | ||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | CWD | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | P | P | P | P | P | p5 | |||
| Intra-operative (Neuro) | P | P | P | P | p5 | ||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | P | P | P | P | P | p5, p8 | |||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | p5 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P5, P8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | p5, p8 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | p5, p8 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Linear Transducer L20-5 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | P5, N11 | |||
| Intra-operative (Specify)7 | P | P | P | P | P | p5 | |||
| Intra-operative (Neuro) | P | P | P | P | p5 | ||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | P | P | P | P | P | p5, p8 | |||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | p5 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | p5, p8 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | p5, p8 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | P | P | P | P | P | p5, p8 | ||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Tran-Esophageal Transducer P8-3TEE | ||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | P | P | P5 | ||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, N10 | ||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other(Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Phased (Sector) Array Transducer P9-3ic ( St.Jude EP ViewFlex PLUS ICE Catheter model # VF- | ||||||||
| PM Part #09-2005 (off the shelf) | |||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| 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 | P | P | P | P | P | P | N10 | ||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| Mode of Operation | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | A2CW (Common name Pencil Probe) | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | |||||||||
| General(Track | |||||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | PWD | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| 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) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | A5CW (Common name Pencil Probe) | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General(Track | PWD | Color | Combined | ||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | 2 | CWD | Doppler3 | Modes4 | Other | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal® | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Fetal Imaging | Testes, etc.) | ||||||||
| & 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 | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | P | |||||||
| vessel | Other(Specify) | ||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
mind 同篇
19
mind
20
21
22
| System: | ZS3, z.one pro Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | Curvilinear Transducer C9-3sp | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | PS, N11 | |||
| Intra-operative (Specify)7.1、7.3 | P | P | P | P | P | p5 | |||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Fetal Imaging | Testes, etc.) | ||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | p5 | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | p5 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | p5 | ||
| vessel | Other (Specify) | ||||||||
| N=new system indication: P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
23
| System: | ZS3, z.one pro Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | Curvillinear Transducer C6-1 | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N³ | |||
| Abdominal® | N | N | N | N | N | N³, Nº1 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N- | |||
| Small Organ (Thyroid, Breast, | |||||||||
| Fetal Imaging | Testes, etc.) | ||||||||
| & 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 | |||||||||
| Other(Specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N- | ||
| vessel | Other (Specify) | ||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, PD, PD, PD, | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI | |||||||||
24
1
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | General(Track | ||||||||
| 1 Only) | Specific(Track 1 & 3) | B | M | PWD | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | N | N | N | N | N5 | |||
| Fetal | N | N | N | N | N | N5 | |||
| Abdominal6 | N | N | N | N | N | N5, N11 | |||
| Intra-operative (Specify)7.1, 7.3 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | N | N | N | N | N | N5 | |||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N5 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N5 | |||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N5 | ||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI |
25
mind/ 道瑞
| System: | ZS3, z.one pro Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | Tran-Esophageal Transducer P8-3mTEE | ||||||||
| 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 | |||||
| 2 | CWD | Color | |||||||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, Breast, | |||||||||
| Testes, etc.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | N5 | ||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N5, N10 | ||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify) | |||||||||
| N=new system indication; P=previously cleared by FDA; | |||||||||
| 1 Includes B-Mode and Harmonic (Contrast) imaging (HI) | |||||||||
| 2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF) | |||||||||
| 3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD) | |||||||||
| 4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD) | |||||||||
| 5 Color M-Mode (CM) | |||||||||
| 6 Abdominal includes renal, GYN/Pelvic | |||||||||
| 7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | |||||||||
| 8 Freehand tissue elasticity | |||||||||
| 9 3D/4D | |||||||||
| 10 CEUS (Contrast agent for LVO) | |||||||||
| 11 CEUS (Contrast agent for Liver) | |||||||||
| 12 ARFI |
26
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.
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 5604 Fax: +86 755 2658 2680
Contact Person:
Zhai Pei 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: June 12, 2017
2. Device Name: ZS3 and z.one pro Ultrasound Systems
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:
The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality.
The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control
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enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.
4. Intended Use:
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative(Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.
5. Summary of Modifications and New Added Features
This submission is modification to ZS3 and z.one pro Ultrasound Systems previously cleared in K151175.
The following is a brief overview of the modifications and new added features.
- Newly added transducers C6-1, C18-5, P8-3mTEE
■ Newly added features ARFI CEUS (Contrast agent for Liver) Add CEUS (Contrast agent for LVO) function to transducers C10-3, P8-3TEE, P9-3ic and P8-3mTEE Smart OB Smart NT Auto EF Auto IMT Stress Echo Anatomical M Needle-Guided bracket NGB-022(cleared in K141010)
6. Comparison to Predicate Devices:
The modified ZS3 and z.one pro Ultrasound Systems are comparable with and substantially equivalent to these predicate devices:
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| Predicate
Device | Manufacturer | Model | 510(k)
Number |
|---------------------|---------------|----------------|------------------|
| 1 | Zonare | ZS3, z.one pro | K151175 |
| 2 | Mindray | DC-8 | K170277 |
| 3 | GE Healthcare | Voluson S8 | K160184 |
| 4 | GE Healthcare | Logiq E9 | K163077 |
| 5 | Mindray | M9 | K152543 |
The modified ZS3 and z.one pro Ultrasound Systems employ 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 has the same intended use as the predicated device ZS3/z.one ■ pro(K151175)
| Items | Subject Device
ZS3/z.one pro | Predicate device
ZS3/z.one pro(K151175) |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ZS3 and z.one pro Ultrasound
Systems are intended for use by a
qualified physician for ultrasound
evaluation of
Opthalmic;
Fetal;
Abdominal (renal, GYN/Pelvic);
Intra-operative (abdominal,
thoracic(cardiac), and vascular);
Intra-operative (Neuro);
Pediatric;
Small organ (thyroid, breast,
testes, etc); Neonatal cephalic;
Adult Cephalic/Transcranial;
Trans-rectal;
Trans-vaginal;
Trans-esoph.(non-Card);
Musculoskeletal(Conventional);
Musculoskeletal(Superficial); | The ZS3 and z.one pro
Ultrasound Systems are
intended for use by a
qualified physician for
ultrasound
evaluation of
Ophthalmic;
Fetal/obstetric,
gynecological;
Abdominal(renal,
GYN/Pelvic);
Intra-operative (abdominal,
thoracic, and vascular),
Intra-operative
neurological;
Pediatric: small organ
(thyroid, breast,
testes, etc),
Adult & Neonatal Cephalic;
Trans-rectal |
29
| Cardiac Adult;
Cardiac Pediatric;
Trans-esoph. (Cardiac);
Intra-cardiac;
Peripheral vessel. | Trans-vaginal,
Trans-cranial,
Trans-esophageal
(non-cardiac and cardiac);
Musculosketal
(conventional &
superficial);
3D/4D;
Cardiac - Adult/ Pediatric/
Fetal;
Echo, Intra-Cardiac;
Pelvic;
Peripheral vascular;
harmonic tissue and
contrast imaging and
Tissue elasticity |
| --------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- . The patient contact materials of the new added transducers and needle-guided bracket are tested under ISO 10993-1.
- The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, . which are the same as the predicated device ZS3 and z.one pro (K151175).
- The modified ZS3 and z.one pro are designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device ZS3 and z.one pro (K151175).
- The modified ZS3 and z.one pro have the same imaging modes as the predicated devices.
- The new added features of modified ZS3 and z.one pro are the same as the predicated devices.
- . The modified ZS3 and z.one pro have similar transducers with the predicated devices.
7. Non-clinical Tests:
ZS3 and z.one pro Ultrasound Systems have 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 requirements for basic safety and essential performance
30
- 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
- . 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 ZS3 and z.one pro Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.