ALOKA ARIETTA 850
Device Facts
| Record ID | K171708 |
|---|---|
| Device Name | ALOKA ARIETTA 850 |
| Applicant | Hitachi Healthcare Americas Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Oct 31, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric |
Intended Use
The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and Peripheral vessel clinical applications. The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging, and 4D Imaging.
Device Story
Multi-functional ultrasound diagnostic scanner; uses linear, convex, radial, and phased array probes. Inputs: ultrasound echoes reflected from body tissues. Operation: digital processing of echo signals; B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, TDI, 3D/4D imaging. Used in clinical settings by trained personnel (doctors, sonographers). Features include Real-time Virtual Sonography (RVS) with magnetic sensor-based Body Motion Tracking, Needle Tracking, 3D Sim-Navigator for puncture planning, and E-field Simulator for RFA treatment. Output: real-time diagnostic images and measurements displayed on screen. Assists clinicians in visualization, guidance of biopsies/procedures, and anatomical assessment. Benefits: non-invasive diagnostic imaging and procedural guidance.
Clinical Evidence
Bench testing only. No clinical data required.
Technological Characteristics
Ultrasound system using linear, convex, radial, and phased array transducers. Digital signal processing with adaptive filters (HI REZ). Connectivity: standard ultrasound interfaces. Software features: RVS (Real-time Virtual Sonography), Body Motion Tracking, Needle Tracking, 3D Sim-Navigator, E-field Simulator, Automated FHR measurement. Conforms to IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, and ISO 10993 standards.
Indications for Use
Indicated for diagnostic ultrasound evaluation of fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, wound, gynecological, cardiac, and peripheral vessel applications in adult and pediatric patients.
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
- ARIETTA 70 (K134016)
Reference Devices
- ALOKA LISENDO 880 (K162583)
- Noblus (K160559)
- HI VISION Ascendus (K153421)
- CIVCO omniTrax bracket (K143396)
- CIVCO VirtuTrax bracket (092619)
Related Devices
- K220295 — ARIETTA 50 · Fujifilm Healthcare Corporation · Apr 29, 2022
- K202422 — Arietta 65 · Hitachi Healthcare Americas · Nov 4, 2020
- K183377 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 4, 2019
- K134016 — ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · Mar 28, 2014
- K190248 — ARIETTA 50 · Hitachi Healthcare Americas · Apr 2, 2019
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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.
Hitachi Healthcare Americas Corporation % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
October 31, 2017
Re: K171708
Trade/Device Name: ALOKA ARIETTA 850 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 24, 2017 Received: October 25, 2017
Dear Mr. Thistlethwaite:
This letter corrects our substantially equivalent letter of October 31, 2017.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
## Page 2 - Mr. Doug Thistlethwaite
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jeff Balygo
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K171708
Device Name ALOKA ARIETTA 850
Indications for Use (Describe)
The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and Peripheral vessel clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging, and 4D Imaging.
Type of Use (Select one or both, as applicable)
X Prescription Use (Pert 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
#### Device Name: ALOKA ARIETTA 850
| | | Intended use: Diagnostic ultrasound imaging or thud flow analysis of the human body as tollows: | | | | | | | | |
|--|--|-------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| | | | | | | | | | | |
| | 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 | 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 | 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 | P | P | P | P | P | P | P |
| | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | Pe |
| | Trans-vaginal | Pf | 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 | P |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | 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 | P | P |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016, K160559 and K153421
*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). Tissue Dopler Imaging, Free Angular M-mode, 3D Imaging, Shear Wave Measurement
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.
- 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
{4}------------------------------------------------
## Device Name: ALOKA ARIETTA 850 Transducer: C22K 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 |
| | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K160559
*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, 3D 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":
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: ALOKA ARIETTA 850 | | | | | | |
|---------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| 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>(Spec.) | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K160559
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D imaging
Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D image
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":
- 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: ALOKA ARIETTA 850 Transducer: C251 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 Imaging<br>& Other | Fetal | P | P | P | P | P | P | P |
| | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K1162583
*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), Tissue Dopler Imaging, Free Angular M-mode, 3D imaging, Shear Wave Measurement
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":
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":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
{7}------------------------------------------------
| Device Name: ALOKA ARIETTA 850 |
|--------------------------------------------------------------------------------------------------|
| Transducer: C252 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| | Clinical Application | | | | | | | | |
|--------------------------|------------------------------------|------------------------------|----|----|-----|-----|----|----|--|
| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | | | |
| | Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | P | P | P | P | |
| | 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 | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |
N = new indication; P = previously cleared in K162583
*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), Tissue Doppler Imaging, Free Angular M-mode, 3D imaging
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
{8}------------------------------------------------
## Device Name: ALOKA ARIETTA 850 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>(Spec.) | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K134016
*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, 3D 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":
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
{9}------------------------------------------------
## Device Name: ALOKA ARIETTA 850 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>(Spec.) | 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 K162583
* 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, CMM-B/CW
**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D 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.
- 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
{10}------------------------------------------------
### Device Name: ALOKA ARIETTA 850 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>(Spec.) | 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 K160559
*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 amnocentesis).
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.
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
{11}------------------------------------------------
## Device Name: ALOKA ARIETTA 850 Transducer: C42K 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 Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K162583
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/W, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW
**Power Doppler (Color Flow Angiography), Free Angular M-mode, 3D 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.
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: ALOKA ARIETTA 850 Transducer: CC41R1 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 | P | P | P | | P | P | P |
| Fetal Imaging<br>& Other | 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) | | | | | | | |
| | 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 K160559
*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 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.
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: ALOKA ARIETTA 850 Transducer: CL4416R 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 | | | | | | | |
| | 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 | | | | | | | |
| | 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 K160559
*Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/W, CFM-B/CFM-M, 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 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.
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}------------------------------------------------
## Device Name: ALOKA ARIETTA 850 Transducer: L34 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.) | | | | | | | |
| | 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.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K162583
* 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, 3D 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.
- 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: ALOKA ARIETTA 850 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>(Spec.) | 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 | | | | |…
