(59 days)
No
The document does not mention AI, ML, or any related terms like deep learning or neural networks. The description focuses on standard ultrasound technology and signal processing.
No
The intended use of the device is for "diagnostic ultrasound evaluation," indicating it is used for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications".
No
The device description explicitly lists hardware components such as ultrasound transducers, a computer system, and a video monitor, indicating it is not a software-only device.
Based on the provided information, the ARIETTA Prologue is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- ARIETTA Prologue Function: The ARIETTA Prologue is an ultrasound diagnostic system. It uses ultrasound waves to create images of internal structures within the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes diagnostic ultrasound evaluation of various clinical applications and anatomical sites within the patient.
- Device Description: The device description details components like transducers, a computer system, and a monitor, all consistent with an ultrasound imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, the ARIETTA Prologue is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGINAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Amplitude Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Omni Directional M mode.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected O echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of O transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected O echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler O data
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
FETAL; ABDOMINAL; INTRA-OPERATIVE (SPEC.); INTRA-OPERATIVE (NEURO.); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, breast, scrotum, penis); NEONATAL CEPHALIC; ADULT CEPHALIC; TRANS-RECTAL; TRANS-VAGINAL; TRANS-ESOPHAGEAL (Non-Cardiac & Cardiac); MUSCULOSKELETAL (CONVENT./SUPERFIC.); WOUND (Cavernous/Non-Cavernous); GYNECOLOGICAL; CARDIAC; PERIPHERAL VESSEL.
Indicated Patient Age Range
Adult/Pediatric, Neonatal Cephalic, Adult Cephalic, Fetal
Intended User / Care Setting
trained personnel (doctor, sonographer, etc.)
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)
No new hazards were identified with the subject device. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Hitachi, Ltd. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Boulevard WALLINGFORD CT 06492
Re: K162902
Trade/Device Name: ARIETTA Prologue Diagnostic Ultrasound System and Transducers Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2016 Received: October 18, 2016
Dear Ms. Van Arsdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
ARIETTA Prologue Diagnostic Ultrasound System and Transducers
Indications for Use (Describe)
ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGIAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Amplitude Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Omni Directional M mode.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Device Name: ARIETTA Prologue
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||
|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging | ||||||||
| & 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 | ||
| Neonatal Cephalic | 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 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Wound) | Ph | Ph | Ph | Ph | Ph | Ph | ||
| Other (Gynecological) | 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 | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/CW, CFM-B/CFM-N, CFM-B/PW, CFM-B/CW
** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 2 of 18
510(K) Premarket Notification - ARIETTA Prologue
4
| Device Name: ARIETTA Prologue |
|---|
| Transducer: C22P |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Fetal Imaging | |||||||||
| & 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 | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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.
Subscript "g": For Adult and pediatric patients
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 3 of 18
5
| Device Name: ARIETTA Prologue |
|---|
| Transducer: C251 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P | |
| 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.) | ||||||||
| 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 K142368
- 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), Tissue Doppler Imaging, 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 4 of 18
6
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: C25P | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | Mode of Operation |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Fetal Imaging | ||||||||
| & 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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
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 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 5 of 18
7
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: C35 | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | Mode of Operation |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | P | P | P | P | P | P | |
| 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.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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), Tissue Doppler Imaging, 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 6 of 18
8
| Device Name: ARIETTA Prologue |
|---|
| Transducer: C41B |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | 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 | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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
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 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 7 of 18
9
| Device Name: ARIETTA Prologue |
|---|
| Transducer: C41V1 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Fetal Imaging | ||||||||
| & 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) | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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
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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 8 of 18
10
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: C42K | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | Mode of Operation |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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 | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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
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 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 9 of 18
11
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: L44 | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | Mode of Operation |
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other**
(Spec.) |
|---------------------------|------------------------------------|----|----|-----|-----|------------------|----------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging
& 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) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 10 of 18
12
| Device Name: ARIETTA Prologue |
|---|
| Transducer: L441 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| 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) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 11 of 18
13
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: L44LA | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| Clinical Application | Mode of Operation |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Spec.) | P | P | P | P | P | P | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | P | P | P | P | P | P | ||
| 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 Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 12 of 18
14
| Device Name: ARIETTA Prologue | |
|---|---|
| Transducer: L53K | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |
| (1iminal American | Mode of Overention |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | 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 Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 13 of 18
15
| Device Name: ARIETTA Prologue |
|---|
| Transducer: L55 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| 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 | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 14 of 18
16
| Device Name: | ARIETTA Prologue |
|---|---|
| Transducer: | L64 |
| Intended use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spe) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & 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 | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, Trapezoid 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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 15 of 18
17
| Device Name: ARIETTA Prologue | |||||
|---|---|---|---|---|---|
| Transducer: S211 | |||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||||
| Doppler | Combined* | |||||||||
| (Spe | Other** | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | |||
| Fetal Imaging | ||||||||||
| & Other | Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ (Spec.) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (Wound) | ||||||||||
| Other (Gynecological) | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | ||
| Trans-esophageal (Adult/Pediatric) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P | ||
| Other (spec.) |
N = new indication; P = previously cleared in K142368
- 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, CFM-B/CW
**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, 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 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
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 16 of 18
510(K) Premarket Notification - ARIETTA Prologue
18
| Device Name: ARIETTA Prologue |
|---|
| Transducer: S31KP |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging | |||||||||
| & Other | Abdominal | ||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | P | P | P | P | P | P | |||
| 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 K134016
- 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
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
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 17 of 18
19
| Device Name: ARIETTA Prologue |
|---|
| Transducer: S3ESEL |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined*
(Spe) | Other**
(Spec.) |
|---------------------------|------------------------------------|----|----|-----|-----|------------------|--------------------|--------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | 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.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Wound) | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication; P = previously cleared in K142368
- 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, CFM-B/CW
**Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, 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 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
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 18 of 18
510(K) Premarket Notification - ARIETTA Prologue
20
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.
21 CFR 807.92, Subsection a
1. Submitter's Information
Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903
On behalf of Hitachi, Ltd. Tokyo, Japan
Primary Contact Person: Angela Van Arsdale R.A. / Q.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Date Prepared: September 7, 2016
- Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name – ARIETTA Prologue Diagnostic Ultrasound system and Transducers Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II Product Code: 90-IYN 892.1550 Ultrasonic Pulsed Imaging System 90-IY0 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer
-
- Legally Marketed Predicate Device(s): NOBLUS (K142368)
-
- Device Description:
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected O echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of O transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected O echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler O data
5. Indication for Use:
ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.) - (Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO.); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.) - (Includes thyroid, breast, scrotum, penis and imaging for guidance of biopsy); NEONATAL CEPHALIC; ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGINAL - (Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL ( Non-Cardiac & Cardiac) - Adult/Pediatric; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC ADULT / PEDIATRIC; PERIPHERAL VESSEL.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Amplitude Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Omni Directional M mode.
21
6. Comparison to predicate device:
| | Subject:
ARIETTA Prologue Diagnostic system
and Transducers | Predicate:
Noblus [K14268] |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLINICAL APPLICATIONS: | Fetal; Abdominal; Intra-operative (Spec.);
Intra-operative (Neuro.); Laparoscopic;
Pediatric; Small Organ (Spec.); Neonatal
Cephalic; Adult Cephalic; Trans-rectal;
Trans-Vaginal; Trans-esophageal (Non-
Cardiac & Cardiac) - Adult/Pediatric;
Musculoskeletal (Convent./Superfic.);
Wound (Cavernous/Non-Cavernous);
Gynecological; Cardiac Adult / Pediatric
and Peripheral Vessel | Fetal; Abdominal; Intra-operative (Spec.);
Laparoscopic; Pediatric; Small Organ
(Spec.); Neonatal Cephalic; Adult Cephalic;
Trans-rectal; Trans-vaginal; Trans-
esophageal (Non-Cardiac & Cardiac) -
Adult/Pediatric; Musculoskeletal
(Convent./Superfic.);Wound
(Cavernous/Non-Cavernous); Gynecology;
Cardiac; Peripheral vessel, Biopsy,
Endoscopy, Intra-luminal, Urology |
| TRACK | 3 | 3 |
| PROBE TYPES | Convex, Linear, Sector | Convex, Linear, Sector, 4D, Other, EUS, Broncho |
| TRANSMIT | | |
| Transmit channel | 64 | 64 |
| Transmit power level | 0 ~ 100% (1% steps) | 5 ~ 100% (5% steps) |
| Transmit frequency | Selectable in 4 steps | Selectable in 5 steps |
| Transmit focus | Max 8 steps electric focusing | Max 10 steps electric focusing |
| RECEIVE | | |
| Number of receive beam | 2 beam | 2 beam (as 64 channels) |
| Receive focus | Continuously variable aperture
dynamic focus | Continuously variable aperture
dynamic focus |
| DISPLAY MODES | B, M, PW, CW and combinations | B, M, PW, CW and combinations |
| Physiological signal display | N/A | Applicable |
| DICOM | Applicable | Applicable |
| DICOM SR | Applicable | Applicable |
| DICOM QR | Applicable | Applicable |
| Automated IMT Measurement | Applicable | Applicable |
| Automated NT Measurement
(Cleared via K140639, K140443, K134016) | Applicable | N/A |
| EFV (Extended Field of View) | Applicable | Applicable (Wide View function) |
| HI REZ / AIP | Applicable (AIP/SIP) | Applicable (HI REZ) |
| DSD (Dynamic Slow Motion Display)
(Cleared via K140639, K140443, K134016) | Applicable | N/A |
| Real-Time Doppler Auto Trace | Applicable | Applicable |
| Spatial Compound | Applicable | Applicable |
| FAM (Free Angular M-mode) | Applicable | Applicable (ODM function) |
| Measurement Function | Applicable | Applicable |
| Trapezoid | Applicable | Applicable |
| TDI | Applicable | Applicable |
| Color Flow | | |
| Reference frequency | 2.08MHz | 2.010MHz |
| PRF | 120Hz20kHz | 120Hz20kHz |
| Linear oblique scan angle | 0°, ±10°, ±15°, ±20° (depending probe) | 0°, ±10°, ±15°, ±20° (depending probe) |
| Color Flow Angiography | Available | Available |
| Built-in Battery | Applicable | Applicable |
| Wireless equipment | Applicable | N/A |
22
21 CFR Part 807.92, Section b
1. Non-clinical Testing
No new hazards were identified with the subject device. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
2. Clinical testing:
None required
3. Conclusions:
The Hitachi, Ltd. ARIETTA Prologue Diagnostic Ultrasound system and Transducers is substantially equivalent in safety and effectiveness to the predicate device;
- The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
- . The subject and predicate device(s) have the same gray scale and Doppler capabilities.
- 트 The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
- . The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
- 트 The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
- . The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
- . The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
- . The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.
END OF SUMMARY