(106 days)
No
The summary does not mention AI, ML, or any related terms, and the description focuses on traditional ultrasound technology and image processing.
No
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation" and to "acquire and display high-resolution, real-time ultrasound data." Its purpose is to provide images for diagnosis, not to treat.
Yes
The Device Description explicitly states "The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems." The Intended Use/Indications for Use also lists various anatomical sites for "ultrasound evaluation," which is a diagnostic purpose.
No
The device description explicitly states it is a "full-featured, general purpose, software controlled, diagnostic ultrasound system" and mentions hardware components like a multi-transducer port and power options (battery/AC), indicating it is a hardware system with integrated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "ultrasound evaluation" of various anatomical sites. This involves using ultrasound waves to create images of internal structures.
- Device Description: The description details a "diagnostic ultrasound system" that acquires and displays real-time ultrasound data.
- Input Imaging Modality: The input modality is explicitly stated as "Ultrasound."
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to obtain information about a patient's health. This ultrasound system operates in vivo (within the body) by using sound waves to visualize internal structures.
Therefore, this device falls under the category of medical imaging devices, not IVDs.
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 Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal 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.
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic (cardiac), and vascular); Intraoperative (Neuro); Laparoscopic; 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.
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), vascular, Neuro), Laparoscopic, Pediatric, Small organ (thyroid, breast, testes, etc.), Neonatal cephalic, Adult Cephalic/Transcranial, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Intra-cardiac, Peripheral vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician. Care setting not explicitly stated but implied to be clinical/medical setting where ultrasound evaluations are performed.
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)
Not Applicable. The subject of this submission. ZS3 and z.one pro Ultrasound Systems. do not require clinical studies to support substantial equivalence.
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.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2019
ShenZhen Mindray Bio-Medical Electronics Co., Ltd. % Jiang Haosen Engineer of Technical Regulation Keji 12th Road South, High-tech Industrial Park, Shenzhen, Guangdong 518057 CHINA
Re: K192410
Trade/Device Name: ZS3 and z.one pro Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 15, 2019 Received: November 18, 2019
Dear Jiang Haosen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192410
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 Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal 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.
| 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
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | P | P | P | P5, P9 | ||
| Abdominal6 | P | P | P | P | P | P | P5, P9, P11, P12, N13 | ||
| Intra-operative (Specify)7 | P | P | P | P | P | P5 | |||
| Intra-operative (Neuro) | P | P | P | P | P | P5 | |||
| Laparoscopic | N | N | N | N | N | N5, N11 | |||
| Pediatric | P | P | P | P | P | P | P5, P9 | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | P | P | P | P | P | P5, p8 | |||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| 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 | P | P5, p8 | |||
| Intravascular | |||||||||
| Cardiac Adult | P1 | P | P | P | P | P | P5, P10 | ||
| Cardiac Pediatric | P | P | P | P | P | P | p5 p10 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, p10 | ||
| Intra-cardiac | P | P | P | P | P | P | P10, N5 | ||
| Other(Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P5, P8, P9 | ||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | Mode of Operation | ||||||||
| General(Track 1 | |||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | N5 | ||
| Abdominal6 | P | P | P | P | P | P | P11, P12, N5,N13 | ||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | N5 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | N5 | ||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P1 | P | P | P | P | P | P10, N5 | ||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | Peripheral vessel | N | 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 | |||||||||
| 13 2D SWI |
4
5
| 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 | Mode of Operation | |||||||
| General(Track 1 | ||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | ||
| Doppler3 | Combined | |||||||
| Modes4 | Other | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | p5, p11 | ||
| Intra-operative (Specify)7 | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | p5 | ||
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic/ | |||||||
| Transcranial | ||||||||
| 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 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 | ||||||||
| 13 2D SWI |
6
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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.) | N | N | N | N | N | N5 | |||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | ||||||||
| Adult Cephalic/ | |||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | p5 | |||
| 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: | 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | ||||
| Fetal | P | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | P | p5, p11 | ||
| 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 | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Fetal Imaging & | |||||||||
| 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, p10 | ||
| Cardiac Pediatric | P | P | P | P | P | P | p5, p10 | ||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | Peripheral vessel | P | P | P | P | P | P | p5 | |
| Other(Specify) | |||||||||
| 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 | Mode of Operation | ||||||||
| General(Track 1 | Color | Combined | |||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Doppler3 | Modes4 | Other | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P5, P9 | |||
| Abdominal6 | P | P | P | P | P | P5, P9, P11 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P5, P9 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic/ | ||||||||
| Other | Transcranial | ||||||||
| 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 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, 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | Combined | Other | |
| Only) | Doppler3 | Modes4 | |||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | P | p5, p11 | ||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | p5 | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Fetal Imaging & | Neonatal Cephalic | P | P | P | P | P | P | p5 | |
| Other | Adult | P | P | P | P | P | P | p5 | |
| Cephalic/Transcranial | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | P1 | P | P | P | P | P | p5, p10 | ||
| Cardiac Pediatric | P | P | P | P | P | P | p5 | ||
| Cardiac | 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, 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler³ | Combined | ||||||||
| Modes⁴ | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p⁵ | |||
| Abdominal⁶ | N | N | N | N | N | N⁵ | |||
| Intra-operative (Specify)⁷ | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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, 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: | Endo-Cavity Transducer E9-4 | ||||||||
| 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 | P | P | P | P | P | p5 | |||
| Abdominal6 | N | N | N | N | N | N5 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P5, P9 | |||
| Abdominal6 | N | N | N | N | N | N5, N9 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| Trans-rectal | P | P | P | P | P | P5, P9 | |||
| Trans-vaginal | P | P | P | P | P | P5, P9 | |||
| 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 | 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 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 | PWD2 | CWD | Color | |||
| Doppler³ | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | P | |||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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 | |||
| Neonatal Cephalic | P | P | P | P | P | p5 | |||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | P | P | P | P | P | p5, p8 | |||
| Neonatal Cephalic | P | P | P | P | P | p5 | |||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | P | P | P | P | p5 | ||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | P | P | P | P | P | p5, p8 | |||
| Neonatal Cephalic | P | P | P | P | P | p5 | |||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color Doppler3 | Combined Modes4 | Other | |
| General(Track 1 Only) | Ophthalmic | P | P | P | P | ||||
| Fetal Imaging & Other | Fetal | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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 | |||
| Neonatal Cephalic | P | P | P | P | P | p5 | |||
| Adult Cephalic/ | |||||||||
| Transcranial | |||||||||
| 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 | |||
| Cardiac | Intravascular | ||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | p5, p8 | |||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | ||||||||
| Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color Doppler3 | Combined Modes4 | Other | ||
| General(Track 1 | |||||||||
| Only) | Ophthalmic | P | P | P | P | ||||
| Fetal Imaging & | |||||||||
| Other | Fetal | P | P | P | P | P | p5 | ||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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 | |||
| Neonatal Cephalic | P | P | P | P | P | p5 | |||
| Adult Cephalic/ | |||||||||
| Transcranial | |||||||||
| 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 | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, P10 | |
| 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 | |||||||||
| General(Track 1 | |||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | 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/ | |||||||||
| Transcranial | |||||||||
| 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 | P | P | P | P | P | P | P10, N5 | ||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | Mode of Operation | ||||||||
| General(Track 1 | |||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 1 | |||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | ||||||||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | Curvilinear Transducer C9-3sp | ||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| 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.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other(Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | p5 | |||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| 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 | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | p5 | |||
| Abdominal6 | P | P | P | P | P | p5, p11 | |||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | p5 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 vessel | P | P | P | P | P | p5 | |||
| 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 |
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
| System: | ZS3, z.one pro Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | Curvillinear Transducer C18-5 | ||||||||
| 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 | PWD2 | 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, p11 | |||
| Intra-operative (Specify)7 | N | N | N | N | N | N5 | |||
| Intra-operative (Neuro) | N | N | N | N | N | N5 | |||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N5 | |||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | P | P | P | P | P | p5 | |||
| Neonatal Cephalic | N | N | N | N | N | N5 | |||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | P | P | P | P | P | p5 | |||
| 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 | |||||||||
| 13 2D SWI |
25
| 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 | PWD2 | 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.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | P | P | P | P | P | P | p5, p10 | |
| 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 | |||||||||
| 13 2D SWI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | L30-8 | ||||||||
| 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 | N | N | N | N | ||||
| Fetal | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | N | N | N | N | N | N5 | |||
| Neonatal Cephalic | N | N | N | N | N | N5 | |||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 | |||
| 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 | |||||||||
| 13 2D SWI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | P7-3c | ||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Intended Use: | |||||||||
| Clinical Application | |||||||||
| General(Track 1 | |||||||||
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | ||||||||
| Modes4 | Other | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | N5 | ||
| Abdominal6 | N | N | N | N | N | N | N5, N11 | ||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N5 | ||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Fetal Imaging & | |||||||||
| Other | Neonatal Cephalic | N | N | N | N | N | N | N5 | |
| Adult Cephalic/ | |||||||||
| Transcranial | N | N | N | N | N | N | N5 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N5, N10 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N5 | ||
| 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, 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 | |||||||||
| 13 2D SWI | |||||||||
| System: | ZS3, z.one pro Ultrasound System | ||||||||
| Transducer: | C12-4lp | ||||||||
| 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 | |||||||||
| Abdominal6 | |||||||||
| Intra-operative (Specify)7 | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | N | N | N | N | N | N5, N11 | |||
| Pediatric | |||||||||
| Small Organ (Thyroid, | |||||||||
| Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | |||||||||
| Other | Adult Cephalic/ | ||||||||
| Transcranial | |||||||||
| 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 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 | |||||||||
| 13 2D SWI |
26
27
28
29
K192410
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 8807.92(c).
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 6183 Fax: +86 755 2658 2680
Contact Person:
Jiang Haosen 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: August 30, 2019
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. Indications for Use:
The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic (cardiac), and vascular); Intraoperative (Neuro); Laparoscopic; 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 K171891.
The following is a brief overview of the modifications and new added features.
- Newly added transducers ■ L30-8, P7-3c, C12-4lp
- . Newly added features 2D SWI CEUS QI Needle OPT TTOA HD Scope Add CM (Color M-Mode) function to transducers C4-1, P9-3ic Protocol MV slope measurement
Newly added Exam Mode . Vascular for C4-1; Small Parts for C9-3; Abdominal for E9-3, E9-4 and E9-3 3D; Intra-operative, Pediatric and NeoHead for C18-5 . Material changed for some previous licensed transducers Mucilage glue is changed from RTV 167 to RTV 162 for transducer C4-1, C6-2, P4-1c, C9-3, C10-3, L8-3, L14-5w, L10-5, L14-5sp.
. Newly added accessories Gel Warmer; wireless Ethernet Routers and Bridges
31
6. Comparison to Predicate Devices:
| Predicate Device | Manufacturer | Model | 510(k)
Number |
|--------------------------------|---------------|----------------|------------------|
| 1. Primary
predicate device | Mindray | ZS3, z.one pro | K171891 |
| 2. Reference
device | Hitachi | NoblusTM | K160559 |
| 3. Reference
device | Mindray | Resona 7 | K171233 |
| 4. Reference
device | GE Healthcare | Logiq P9 | K181783 |
The modified ZS3 and z.one pro Ultrasound Systems are comparable with and substantially equivalent to these predicate devices:
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 indications for use and basic operating modes as the predicate devices.
- . Subject device has the same indications for use as the predicated device ZS3/z.one pro(K171891); laparoscopic as the predicated device NOBLUS™ (K160559)
- The patient contact materials of the new added transducers, material changed transducers and newly added intra-operative application for previous licensed transducers 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 (K171891).
- 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 (K171891).
- . 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.
- 1 The modified ZS3 and z.one pro have similar transducers with the predicated devices.
7. Non-clinical Tests:
32
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 ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- . IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
- . ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
- . NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
8. Clinical Tests:
Not Applicable. The subject of this submission. ZS3 and z.one pro Ultrasound Systems. do not require clinical studies to support substantial equivalence.
Conclusion:
Indications for Use 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.
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