ARIETTA 750
Device Facts
| Record ID | K191233 |
|---|---|
| Device Name | ARIETTA 750 |
| Applicant | Hitachi Healthcare Americas |
| Product Code | IYN · Radiology |
| Decision Date | Aug 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.
Device Story
The ARIETTA 750 is a multi-functional diagnostic ultrasound scanner used by trained clinicians (doctors, sonographers) in clinical settings. It utilizes various transducer types (linear, convex, radial, phased array) to emit and receive ultrasound waves, forming images through digital scanning conversion. The device supports B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, Tissue Doppler, and 3D/4D imaging. It employs adaptive filters (HI REZ) to enhance image quality. The system processes ultrasound signals to display tomographic images, blood flow information (direction, speed, inconsistency), and anatomical structures. Clinicians use these outputs for diagnostic evaluation and guidance of procedures like percutaneous biopsies. The device benefits patients by providing non-invasive diagnostic imaging and hemodynamic analysis across a wide range of clinical applications.
Clinical Evidence
No clinical data was required. Substantial equivalence was established through bench testing, including acoustic output, biocompatibility, electromagnetic compatibility, and electrical/mechanical safety testing in accordance with AAMI/ANSI/IEC standards.
Technological Characteristics
Multi-functional digital ultrasound system supporting linear, convex, radial, and phased array transducers. Features include B-mode, M-mode, PW/CW Doppler, Color Flow Mapping, Power Doppler, Tissue Doppler, and 3D/4D imaging. Employs adaptive filters (HI REZ) for image enhancement. Conforms to IEC 60601-1 (safety), IEC 60601-2-37 (ultrasound performance), and IEC 60601-1-2 (EMC). Biocompatibility per ISO 10993.
Indications for Use
Indicated for diagnostic ultrasound evaluation of fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, wound, gynecological, cardiac, and peripheral vessel applications in adult and pediatric populations.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ALOKA ARIETTA 850 (K183456)
Reference Devices
- ARIETTA 70 Diagnostic Ultrasound Scanner (K134016)
- ARIETTA 65 Diagnostic Ultrasound Scanner (K181376)
- PROSOUND ALPHA 7 (Intra-operative Ultrasound Transducer)
- ARIETTA 70 Diagnostic Ultrasound System (K142618)
Related Devices
- K181376 — ARIETTA 65 · Hitachi Healthcare Americas Corporation · Jul 18, 2018
- K183456 — Aloka Arietta 850 · Hitachi Healthcare Americas · Jan 28, 2019
- K173739 — ALOKA ARIETTA 850 · Hitachi Healthcare Americas Corporation · Feb 28, 2018
- K220295 — ARIETTA 50 · Fujifilm Healthcare Corporation · Apr 29, 2022
- K202422 — Arietta 65 · Hitachi Healthcare Americas · Nov 4, 2020
Submission Summary (Full Text)
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August 9, 2019
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Hitachi Healthcare Americas % Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K191233
Trade/Device Name: ARIETTA 750 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 11, 2019 Received: June 12, 2019
Dear Aaron Pierce:
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/cfpmp/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 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
{1}------------------------------------------------
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,
For
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
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## Indications for Use
510(k) Number (if known) K191233
Device Name ARIETTA 750 Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use (Describe)
The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.
The Modes of Operation are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
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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Device Name: ARIETTA 750
| Intended use: Diagnostic ultrasound imaging or thud flow analysis of the human body as follows | | | | | | |
|------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | |
| | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | |
|---------------------------|------------------------------------|----|-------------------|-----|-----|------------------|---------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe.) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | P | P | P | | P | P | P |
| | Laparoscopic | P | P | P | | P | P | P |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | Ph | Ph | Ph | Ph | Ph | Ph | Ph |
| | Other (Gynecological) | P | P | P | | P | P | P |
| | Cardiac Adult | P | P | P | | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | | P | | P |
| | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | P | P | | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K160559
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
** Power Dopler (Color Flow Angiography), Free Angular M-mode, Tissue Dopler Imaging, Shear Wave Measurement, Real time 3D Imaging, 4D Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{4}------------------------------------------------
### Device Name: ARIETTA 750 Transducer: C252 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application<br>Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| & Other | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | b | P | P | P | P | b |
| | Small Organ (Spec.) | bd | Pd | Pd | bd | bd | bd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
** Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging, Shear Wave Measurement
#### Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{5}------------------------------------------------
## Device Name: ARIETTA 750
Transducer: C253
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application<br>Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/W B/CW, CFM-B/CW
**Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging, Shear Wave Measurement
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{6}------------------------------------------------
## Device Name: ARIETTA 750
Transducer: C35
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | | | | Mode of Operation | | |
|---------------------------|------------------------------------|----|----|-----|-----|-------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | b | P | P | b | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | bd | Pd | bd | bd | bd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
- **Power Doppler (Color Flow Angiography), Free Angular M-mode, Tissue Doppler Imaging
Additional Comments:
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
{7}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: C22P Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | | | | Mode of Operation | | | |
|---------------------------|------------------------------------|----|----|-----|-----|-------------------|-------------------|--------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Wound) | | | | | | | | |
| | Other (Gynecological) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
- Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
- Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
- Subscript "e": Includes imaging for guidance of trans-rectal biopsy
- Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
- Subscript "g": For Adult and pediatric patients
- Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{8}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: C25P Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|--------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
#### Additional Comments:
- Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
{9}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: C41V1 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
- Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{10}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: C41B Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|--------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode,
#### Additional Comments:
- Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
{11}------------------------------------------------
## Device Name: ARIETTA 750
Transducer: C42
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
**Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
- Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{12}------------------------------------------------
### Device Name: ARIETTA 750 Transducer: L441 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
**Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
- Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
- Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{13}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: L442 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application<br>Mode of Operation | | | | | | | |
|---------------------------|-------------------------------------------|----|----|-----|-----|------------------|-------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | P | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K173739, K181376
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW B/CW, CFM-B/CW
**Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
- Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
- Subscript "g": For Adult and pediatric patients
- Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{14}------------------------------------------------
| | Clinical Application | | | | | | Mode of Operation | | | |
|--------------------------|---------------------------|------------------------------------|----|----|-----|-----|-------------------|----------------------|--------------------|--|
| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) | |
| | Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | Fetal | | | | | | | | |
| | | Abdominal | | | | | | | | |
| | | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb | |
| | | Intra-operative (Neuro.) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | | | | | | | | |
| | | Small Organ (Spec.) | | | | | | | | |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | | |
| | | Musculo-skel. (Convent.) | | | | | | | | |
| | | Musculo-skel. (Superfic.) | | | | | | | | |
| | | Intra-luminal | | | | | | | | |
| | | Other (Wound) | | | | | | | | |
| | | Other (Gynecological) | | | | | | | | |
| Cardiac | Cardiac Adult | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | |
| | | Trans-esophageal (Adult/Pediatric) | | | | | | | | |
| | | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | Peripheral vessel | | | | | | | | |
| | | Other (spec.) | | | | | | | | |
## Device Name: ARIETTA 750 Transducer: L53K
Other (spec.) N = new indication; P = previously cleared in K173739
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
- Subscript "'d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
- Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{15}------------------------------------------------
## Device Name: ARIETTA 750 Transducer: L55
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|----|-----|-----|------------------|--------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spe) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | Ph | Ph | Ph | | Ph | Ph | Ph |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Car…
