ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
Device Facts
| Record ID | K134016 |
|---|---|
| Device Name | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER |
| Applicant | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical |
| Product Code | IYN · Radiology |
| Decision Date | Mar 28, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Hitachi Aloka Medical, Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
Device Story
Diagnostic ultrasound system; utilizes transducers to transmit energy and detect reflected echoes; computer system analyzes signals; video monitor displays images/Doppler data. Used in clinical settings (e.g., clinic, OR) by trained personnel (physicians, sonographers). Supports multiple modes: B-mode, PW/CW Doppler, Color Doppler, TDI, 3D/4D imaging, Real-time Tissue Elastography, and Real-time Virtual Sonography. Output assists clinicians in diagnostic evaluation and fluid flow analysis; aids clinical decision-making by providing anatomical and physiological visualization. Benefits include non-invasive diagnostic imaging across diverse clinical applications.
Clinical Evidence
No clinical data required. Substantial equivalence supported by non-clinical testing, including acoustic output, biocompatibility (ISO 10993-1), cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety testing.
Technological Characteristics
Ultrasound diagnostic system; transducers generate/detect energy. Materials tested per ISO 10993-1. Modes: B, M, PW/CW Doppler, Color Doppler, TDI, 3D/4D, Elastography, RVS. Connectivity: DICOM (SR, QR). Software: Automated measurement functions (IMT, NT, etc.). Safety: Acoustic levels below Track 3 FDA limits. Sterilization: Reusable transducers with provided cleaning/disinfection instructions.
Indications for Use
Indicated for diagnostic ultrasound evaluation of abdominal, cardiac, intra-operative, fetal, pediatric, small organ, peripheral vessel, biopsy, trans-rectal, trans-vaginal, musculoskeletal, neonatal/adult cephalic, endoscopic, intra-luminal, gynecological, urological, and laparoscopic applications by trained clinicians.
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
- Hitachi HI VISION Ascendus Diagnostic Ultrasound Scanner (K110673)
- Hitachi Prosound F75 Diagnostic Ultrasound Scanner (K123828)
Related Devices
- K110673 — HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Medical Systems America, Inc. · Sep 27, 2011
- K181637 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 9, 2019
- K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 13, 2019
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 9, 2023
Submission Summary (Full Text)
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### Hitachi Aloka Medical, Ltd.
K134016
Page 1 of 3
# 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, Ltd. 10 Fairfield Boulevard Wallingford, CT 06492-5903
Contact: Angela Van Arsdale RA/QA Manager
Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Date Prepared: December 18, 2013
2. Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name - Arietta70 / AriettaV70 Diagnostic Ultrasound System 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-IYQ 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer
3. Legally Marketed Predicate Device(s):
Hitachi HI VISION Ascendus Diagnostic Ultrasound Scanner [K110673] Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]
#### 4. Device Description:
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes ಂ
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
- o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs
- O A video monitor with optional image recorder - to display the computed image or derived Doppler data
- 5. Indication for Use:
The Hitachi Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
510(K) Premarket Notification - Arietta 70 / Arietta S70 / Arietta V70 Ultrasound Diagnostic System and Probes
{1}------------------------------------------------
#### Hitachi Aloka Medical, Ltd.
6. Comparison to predicate device:
The Hitachi Aloka Medical. Ltd. AriettaS70 / AriettaV70 Diagnostic Ultrasound device is technically comparable. and substantially equivalent to the HI VISION Ascendus Diagnostic Ultrasound Scanner [K 110673] and Hitachi Prosound F75 Diagnostic Ultrasound Scanner |K123828|. The subject and predicate systems that incorporate the same fundamental and scientific technologies. Both the subject and predicate device systems have the same intended use/ indications for use.
| | Subject | Predicates | |
|------------------------------------|---------------------------------------------------------------------------------|----------------------------------|-------------------------|
| Function | Hitachi Aloka<br>Medical, Ltd.<br>Arietta 70*/<br>Arietta S70*/<br>Arietta V70* | Hi Vision<br>Ascendus<br>K110673 | Prosound F75<br>K123828 |
| Color Flow | X | X | X |
| TDI (Tissue Doppler Imaging) | X | X | X |
| Trapezoid | X | X | X |
| Measurement function | X | X | X |
| Dual Doppler | X | X | X |
| Marking assist display | X | X | NA |
| Real-time Doppler Auto Trace | X | X | X |
| Spatial Compound | X | X | X |
| FAM (Free Angular M-mode) | X | X | X |
| HI REZ/ AIP | X | X | X |
| EyeballEF | X | X | NA |
| DSD (Dynamic Slow motion Display) | X | NA | X |
| CHI/ CHE | X | X | X |
| EFV (Extended Field of View) | X | X | X |
| Stress Echo | X | X | X |
| DICOM | X | X | X |
| DICOM SR | X | X | X |
| DICOM QR | X | X | X |
| Real-time Tissue Elastography | X | X | X |
| RVS (Real-time Virtual Sonography) | X | X | NA |
| Picture in Picture | X | X | NA |
| Freehand 3D | X | X | X |
| Real-time 3D | X | X | X |
| 3D STIC | X | X | X |
| Automated IMT measurement | X | X | X |
| Automated NT measurement | X | NA | X |
| ET (eTracking/ echo Tracking) | X | NA | X |
| FMD (Flow Mediated Dilatation) | X | NA | X |
*The Hitachi Arietta 70 / Arietta S70 / Arietta V70 are cxactly the exception of different color outer shell.
510(K) Premarket Notification - Arietta 70 / Arietta S70 / Arietta V70 Ultrasound Diagnostic System and Probes
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K134016
Page 3 of 3
# 21 CFR Part 807.92. Section b
- 1. Non-clinical Testing
No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompaibility, cleaning & disinfection effectiveness, clectromagnetic 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 Aloka Medical, Ltd. AriettaS70/ AriettaV70 Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device;
- 1 The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
- 해 The subject and predicate device(s) have the same gray scale and Doppler capabilities.
- 피 The subject and predicate device(s) have the same essential technology for imaging. Doppler functions, and sienal processing.
- . The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
- l 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.
- l 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
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of a stylized caduceus, which is a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014 Hitachi Aloka Medical, Ltd. (Hitachi Aloka Medical America) % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-7502
Re: K134016
Trade/Device Name: Arietta70 / AriettaV70 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 24, 2014 Received: January 29, 2014
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.
This determination of substantial equivalence applies to the following transducers intended for use with the Arietta 70/Arietta V70 Diagnostic Ultrasound Scanner, as described in your premarket notification:
| | Transducer Model Number | |
|------------|-------------------------|------------|
| C251 | C41V1 | C41V |
| CC41R | R41R | C42T |
| L64 | S12 | VC34 |
| VC41V | C41L47RP | UST-2265-2 |
| UST-5293-5 | UST-52126 | C41 |
| C42 | C35 | C22P |
| C25P | C41RP | C42K |
| L34 | L441 | L55 |
| L46K | S31 | S31KP |
| VL54 | UST-2266-5 | UST-5418 |
{4}------------------------------------------------
# Page 2-Ms. Van Arsdale
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 (OS) regulation (21 CFR Part 820); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.
for
Janine M. Morris 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) KI34016
#### Device Name
Hitachi Arietta70/AriettaS70/AriettaV70 Ultrasound Diagnostic System
#### Indications for Use (Describe)
The Hitachi Aloka Medical, Ltd. ArietaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiatic, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Dopler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
T Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
TTTT FOR FDA USE ONLY .............................................................................................................................................................................. : ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 413-6740
{6}------------------------------------------------
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."
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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lirans-recial
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Other (spec.) Peripheral vessel
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| | 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.) | Pb | Pb | Pb | | Pb | Pb | Pb | |
| | Intra-operative (Neuro) | P | P | P | | P | P | P | |
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# Device Name: Hitachi Arietta 70 / Ariella S70 / Arietta V70
N = new indication. P = previously cleared in K123828 and K130308
· Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
· Committer of techning move by Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elassognphy, Real Time Virtual Sonography
Additional Comments:
Cardiac
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| 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<br>(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 pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
| | 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 I lealth Office of In Viro Diagnostics and Radiological Health 210(k)
Page 2 of 32
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510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{8}------------------------------------------------
#### Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: (.35)
Intended use: Diagnostic ultrasound imaging or fuid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|-----------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & II) | 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 | 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 (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication P = previously cleared in KH10673
*Combination of each operating mode, B, M, PWD, and Color Doppler
• Comminded of cach of claim Flow Anglogaphy ), Tissite Duppler Imaging, 3D Imaging, Real Time Virtual Sonography
Additional Comments
theludes imaging for guidance of percutanents bropsy of abdumnal organs and stractures (ancluding anniocentess) Subscript "u"
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Subscript "€"* Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathytoid, breast, scrotum, pens, and imaging for guidance of biopsy, Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript " e
Includes imaging for guidance of trans-vagmal bropsy Subscript "T"
For pediatric patients Subscript ¨g `:
Includes imaging for guidance of trans-rectal biopsy Subscript "h"
Prescription Use Only (Per 21 CFR 501,109)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Fitro Diagnostics and Radiological Health (OR)
(Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health う (()(k)______________________________________________________________________________________________________________________________________________________________________
Page 3 of 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{9}------------------------------------------------
Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transduccr: C41V1
Intended use: Diagnostic ultrasound imaging or Nuid Now 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 | Abdominal | | | | | | | |
| & Other | 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 (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) Gynecological | P | P | P | | P | P | P |
N = new indication P = previously cleared in K 1 3030X
· Combination of each operating mode, B. M. PWD, and Color Doppler
• Ampiltude Doppier (Color Flow Angiography). 3D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography
Addinonal Comments
Includes imaging for guidance of perculancous hiopsy of abduminal organs and structures (including amniocentesis). Subscript "อ":
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures)
Includes thyroid, parathyroid, breast, scrotum, and penis Subscript "c":
Includes thyroid, parathyroid, breast, scrotum, penis, and maging for guidance of biopsy. Subscript "d",
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Includes imaging for guidance of trans-vaginal biopsy Subscript "f":
Subscript "g": For pediauric patients
Includes imaging for guidance of trans-rectal biopsy. Subscript "h":
Prescription Use Only (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BEI.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Fleath (OIR)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k)
Page 4 of 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{10}------------------------------------------------
#### Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C4 I V
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 (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) Gynecological | P | P | P | | P | P | P |
N = new indication. P = previously cleared in K130308
· Combination of each operating mode, B. M. PWD, and Color Doppler.
** Amplitude Doppler (Color Flow Angiography). 3D Imaging. Real Time Tissue Elastography. Real Time Virtual Sonography
Additional Commons:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
|----------------|--------------------------------------------------------------------------------------------------------------------|
|----------------|--------------------------------------------------------------------------------------------------------------------|
Includes imaging of organs and structures exposed during surgery Subscript "b":
- (excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
- Includes thyroid, parathyroid, breast, scrowm, penis, and imaging for guidance of biopsy. Subscript *di":
Includes imaging for guidance of trans-rectal biopsy Subscript "c".
Includes maging for guidance of trans-vaginal bropsy Subscript "1"
For nediatric patients Subscript "g".
Includes imaging for guidance of trans-rectal biopsy 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 Fitro 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 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{11}------------------------------------------------
| Device Name: | Hitachi Arietta 70 / Arietta S70 / Arietta V70 |
|---------------|-----------------------------------------------------------------------------------|
| Transducer: | CC41R |
| 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 | CWI | 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 | Pc | Pc | Pc | | Pc | Pc | Pc |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in K110673
· Combination of each operating mode, B. M. PWD, and Color Duppler.
· Ampliade Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Nastography, Real Time Virtual Sonography
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<br>(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 pediatric patients |
| Subscript "h": | Includes imaging for guidance of trans-rectal biopsy. |
| | 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 Viro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In I itro Diagnostics and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________
Page 6 of 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{12}------------------------------------------------
#### Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 R41R Transducer:
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 1 & 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 | P | P | P | | P | P | P |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in K130308
· Combination of each operating mode, B. M. PWD, and Color Doppler.
· Ampliude Doppler (Color Flow Anglography), 3D Imaging, Real Turne Tissue Elastography
Additional Comments
Includes imaging for guidance of perculancous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Includes imaging of organs and structures exposed during surgery Subscript "b":
- (excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c".
- Includes thyroid, parathyroid, breast, scrotum, penis, and maging for guidance of biopsy. Subscript "d":
Includes maging for guidance of trans-rectal biopsy Subscript "c"
- Subscript "I" Includes imaging for guidance of trans-vaginal hiopsy
- Subscript "'g": For pediatric patients
- Subscript "h" Includes maging for guidance of trans-rectal bropsy.
Prescription Use Only (Per 21 CFR 801,109)
# (PLEASE DO NOT WRITE BEI.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CI)RH, Office of In I'iro 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 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{13}------------------------------------------------
#### Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: C42T
Intended use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks 1 & 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.) | P | P | P | | P | P | P |
| | 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 (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in KI 10673
* Combination of each operating mode, B. M. PWD, and Colur Doppler
* Amplitude Dopper (Color Flow Angiography), 3D Inaging, Real Time Tissue Filastography, Real Time Virtual Sonveraphy
Additional Comments:
Subscript "a": Includes imaging for guidance of perculunenas bionsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrorum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "c":
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
For pediatric patients Subscript "g":
Subscript "h": Includes imaging for guidance of trans-rectal biopsy.
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 Firm 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 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{14}------------------------------------------------
#### Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: 1.64
Intended use: Diagnostic ultrasound imaging or Nuid Now 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.) | | | | | | | |
| | 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. (Supertic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in KI30308
· Combination of each operating mode, B. M. PWD, and Color Doppler.
· Amplitude Doppler (Color Flow Angiography). Real Time Tissue Elastography
#### Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis) |
|----------------|-------------------------------------------------------------------------------------------------------------------|
|----------------|-------------------------------------------------------------------------------------------------------------------|
Subscript "b": Includes imaging of organs and structures exposed during surgery
(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrown, and penns Subscript "c"
Includes thyroid, parathyroid, breast, servitum, penis, and maging for guidance of bropsy Suhscript "d"
Includes imaging for guidance of trans-rectal biopsy Subscript "c"
Includes imaging for guidance of trans-vagunal bropsy Subscript "f"
For pediatric patients Subscript "g"
Includes imaging for guidance of trans-rectal bropsy. 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 Viro Diagnostics and Radiological Health (OIR)
(Division Sign-Ofl) Division of Radiological Health Office of In Firo Diagnostics and Radiological Health 510(k)
Page 9 of 32
510[K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{15}------------------------------------------------
#### Device Name: Hilachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: SI2
Intended use: Diagnostic ultrasound imaging or thuid thow 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 | Abdominal | P | P | P | P | P | P | P |
| & Other | 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. (Supertic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (card ) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in K110673
· Combination of each operating mode, B. M. PWD, CWD and Color Doppler.
• Ampliude Doppler (Color Flow Angiography). Tissue Donnier Imaging, 3D Imaging, AD Imaging, Real Time Tissue Elastography
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis) |
|----------------|-------------------------------------------------------------------------------------------------------------------|
|----------------|-------------------------------------------------------------------------------------------------------------------|
- Includes imaging of organs and structures exposed during surgery Subscript "b"
- (excluding neurosurgery and laparoscopic procedures).
- Includes thyroid, parathyroid, breust, scrotum, and penis. Subscript "c":
- Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of bionsy. Subscript "d":
- Includes imaging for guidance of trans-rectal biopsy Subscript "c":
Includes imaging for guidance of trans-vaginal bionsy. Subscript "f":
For pediatric patients Subscript "g":
Includes imaging for guidance of trans-rectal biopsy. Subscript "h":
Prescription Use Only (Per 2) CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
> (Division Sign-Off) Division of Radiological Health Office of In Fitro Diagnostics and Radiological Health 510(k)
Page 10 of 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{16}------------------------------------------------
Device Name: Hitachi Arietta 70 / Arietta S70 / Arietta V70 Transducer: VC34
Diagnostic ultrasound imaging or fluid Now analysis of the human body as follows: Intended use:
| 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 | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro ) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) Gynecological | P | P | P | | | | |
N = new indication. P = previously cleared in KI 110673
* Combination of each operating mode. B. M. PWD, and Color Doppler.
· Amplitude Doppler (Color Flow Angiography). Tissue Doppler Imaging, 3D Imaging
Additional Comments:
Includes imaging for guidance of perculaneous hiopsy of abdominal organs and structures (including amniocentusis) Subscript "a":
Includes imaging of organs and structures exposed during surgery Subscript "b":
(excluding neurosurgery and laparoscopic procedures).
Includes thyroid, parathyroid, breast, scrotum, and penis. Subscript "c":
Subscript "d": Includes thyroid, parathyroid, breast, scrowm, penis, and imaging for guidance of biopsy.
Includes imaging for guidance of trans-rectal hiopsy Subscript "c":
Subscript "1": Includes imaging for guidance of trans-vaginal hiopsy.
For pediatric patients Subscript "g"-
Includes imaging for guidance of trans-rectal biopsy. 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-Ofl) Division of Radiological Health Office of In I'm Diagnostics and Radiological Health 510(k)
Page 11 of 32
510(K) Premarket Notification - Arietta 70 Ultrasound Diagnostic System and Probes
{17}------------------------…
