HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
Device Facts
| Record ID | K110673 |
|---|---|
| Device Name | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER |
| Applicant | Hitachi Medical Systems America, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 27, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The HI VISION Ascendus 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 of the HI VISION Ascendus are B mode. M mode. PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
Device Story
Diagnostic ultrasound system; utilizes transducers to emit acoustic waves (1-20 MHz) and detect reflected echoes; computer system processes signals to generate images or Doppler data; displayed on video monitor. Used in clinical settings (e.g., clinic, OR) by trained personnel (physicians, sonographers). Provides real-time visualization of internal structures and blood flow; supports B-mode, M-mode, PW/CW Doppler, Color Doppler, TDI, 3D imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography. Output assists clinicians in diagnostic evaluation, biopsy guidance, and surgical planning; facilitates improved patient management through non-invasive imaging.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence is based on identical technological characteristics and performance to the predicate device.
Technological Characteristics
Ultrasound imaging system utilizing transducers (1-20 MHz) for acoustic wave generation/reception. Hardware and software architecture identical to predicate. Modes: B, M, PW/CW Doppler, Color Doppler, TDI, 3D, Elastography, Virtual Sonography. Connectivity: Video monitor/recorder. Sterilization: Not applicable (transducers are reusable/disinfectable).
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring evaluation of abdominal, cardiac, fetal, pediatric, small organ, peripheral vessel, musculoskeletal, neonatal/adult cephalic, gynecological, urological, and laparoscopic applications. Contraindications: None stated.
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
- HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)
Related Devices
- K134016 — ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · Mar 28, 2014
- K163690 — 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. · Apr 20, 2017
- 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
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2, 2012
- 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)
{0}------------------------------------------------
| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371<br>ph: (330) 425-1313<br>fax: (330) 963-0749 | SEP 27 2011 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Douglas J. Thistlethwaite | |
| Date: | March 3, 2011 | |
# Submitter Information
# Device Name
| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic |
|-------------------------|-----------------------------------------------------------|
| Classification Number: | 90-IYN |
| Trade/Proprietary Name: | HI VISION Ascendus Diagnostic Ultrasound Scanner |
| Predicate Device(s): | HI VISION Preirus Diagnostic Ultrasound Scanner (K093466) |
# Device Intended Use
The HI VISION Ascendus 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 of the HI VISION Ascendus are B mode. M mode. PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
# Device Description
# Function
An ultrasound system consists of the following:
- . Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- . A video monitor with optional image recorder to display the computed image or derived Doppler data
# Scientific Concepts
An acoustic wave is a mechanical perturbation of a medium which passes through a given medium at a fixed velocity. The rate at which the particles in the medium vibrate in the disturbance is the frequency of the wave, and is measure as cycles/second, or hertz (Hz), Frequencies above 20 kHz are not audible, and above this frequency, the acoustic energy is known as ultrasound. For the purposes of medical ultrasound imaging, frequencies in the range of 1-20 MHz are utilized.
{1}------------------------------------------------
The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echo.
The ultrasound transducer, when operating in pulsed mode, periodically emits an ultrasound burst at a predetermined rate described as the pulse repetition frequency (PRF). During the time duration that the transducer is not transmitting ultrasound energy, it may act as a received for the reflected ultrasound energy. Since the speed of propagation of ultrasound in tissues is estimated as 1540m/sec. the time elapsed between transmission of a pulse and receipt of an echo may be used to estimate the distance from the transducer to the tissue structure giving rise to the reflected echo. The relative strength of the reflected echo can be used to determine the brightness of display of the reflected echo or strength of derived Doppler signal.
# Physical and Performance Characteristics
The principle of operation of ultrasound imaging involves generation of an ultrasound wave with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adiacent transducer from the various tissues along the ultrasound wave.
# Device Technological Characteristics
The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device. See Section 4 - Predicate Device Comparison.
# Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that HI VISION Ascendus Diagnostic Ultrasound Scanner is substantially equivalent to the predicate devices. In addition, we have concluded that the subject system is substantially equivalent with respect to safety. effectiveness, and functionality to the HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)
# Attachment
| ATTACHMENT | POSITION |
|------------------------------------------------|----------|
| Declaration of Conformity with Design Controls | 1 |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle. The bird is depicted with simple, curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Doug Thistlethwaite Manager. Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OF 44087
SEP 27 2011
Re: K110673
Trade/Device Name: HI VISION Ascendus Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. 1YO. and ITX Dated: August 29, 2011 Received: August 31. 2011
Dear Mr. Thistlethwaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent ffor 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the HI VISION Ascendus Diagnostic Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
| EUP-B512 | EUP-CV524 | EUP-L53L |
|-----------|-----------|-----------|
| EUP-B514 | EUP-CV714 | EUP-L54MA |
| EUP-B715 | EUP-CV724 | EUP-L65 |
| EUP-C511 | EUP-ES52E | EUP-L73S |
| EUP-C514 | EUP-ES52M | EUP-L74M |
| EUP-C524 | EUP-F334 | EUP-L76 |
| EUP-C532 | EUP-F531 | EUP-LV74 |
| EUP-C715 | EUP-L52 | EUP-O53T |
| EUP-CC531 | EUP-L53 | EUP-O54J |
{3}------------------------------------------------
| . M<br><br>Annual The Fits and any<br>:<br>1<br>1<br>-4-4-4-4<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 155 - 10<br>ﻟ<br>:<br>:<br>-----------<br>ﻟﻠﻘﻢ ﺍﻟﻤﺴﺎﻫﻤﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ<br>---- | <br>t<br>l<br>I |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ﻟ<br>(<br><br>:<br>1<br>1200<br>I | land of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state the state of the state of the state the<br>i<br><br>l<br>No. of Children and Charles a | r " "<br>:<br>) I<br>-<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| r<br>I<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A LAND SCHEAR LE RE | ក<br>11, 109, 14<br>4<br>1<br>1<br>A REAL LA | 1<br><br>l<br> |
| -<br>----<br>ﺔ ﺍﻟﺘﻲ ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ<br>Angel Park | I<br><br>t<br>r<br>l<br>ﺎ<br><br> | |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be Tound in the Code of Federal Regulations. Title 21. Parts 800 to 895. In addition. FDA may publish further announcements concerning vour 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRF/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter. please contact Lauren Hefner at (301) 796-6881
Sincerely Yours.
Mary S. Pottle
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
# Indications for Use
# 510(k) Number (if known): KUO673
# Device Name: HI VISION Ascendus Diagnostic Ultrasound Scanner
Indications For Use:
The HI VISION Ascendus 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, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation of the HI VISION Ascendus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Kil0623
Page 1 of *_*_
{5}------------------------------------------------
| 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 |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | 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 |
| Fetal Imaging | Adult Cephalic | P | P | P | P | P | P | P |
| & Other | Trans-rectal | Ph | Ph | Ph | | Ph | Ph | Ph |
| | Trans-vaginal | Pf | Pf. | Pf | | Pf | Pf | Pf |
| | 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 (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P |
| | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans esophageal (card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication. P = previously cleared in K093466
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography
Additional Comments:
System:
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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Settle
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number: K110673
{6}------------------------------------------------
System: Transducer
EUP-B512
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis if 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 | |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Other | 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<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N = new indication. P = previously cleared in K093466
* Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Patel
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number: K110673
{7}------------------------------------------------
Transducer: EUP-B514
System:
| 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 |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | 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 | Peripheral vessel | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication. P = previously cleared in K093466
Other (spec.)
* Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Virtual Sonography
Additional Comments:
Vessel
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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
CON ANU' Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Sadoff
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K110673
{8}------------------------------------------------
System: Transducer:
EUP-B715
| Clinical Application | | Mode of Operation | | | | | | Other**<br>(Spec.) |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | P |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
Intended use Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication. P = previously cleared in K093466
* Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Manys Petty
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K110623
{9}------------------------------------------------
Transducer EUP-C511
System:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if 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 |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging | Adult Cephalic | | | | | | | |
| & Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P |
| | Cardiac Pediatric | P | P | P | | P | P | P |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P |
| Vessel | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in K093466
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mura S. Patil
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K110673
{10}------------------------------------------------
System: Transducer:
EUP-C514
# Intended use Diagnostic ultrasound imaging or fluid flow analysis if 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 | |
| | 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 | | | | | | | | |
| Fetal Imaging<br>& Other | 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<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N = new indication. P = previously cleared in K093466
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF-NEEDED) |
WRITE RELOW Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Patel
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number: K110673
{11}------------------------------------------------
Transducer EUP.C524
System:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows Ann Reatin
| 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 |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pc | Pc | Pc | | Pc | Pc | Pc |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared in K093466
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging
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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mass Patil
(Division Sign-Off
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number:
{12}------------------------------------------------
System: Transducer:
EUP-C532
| 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 | | | | | | | | |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa | |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd | |
| | Neonatal Cephalic | P | P | P | | P | P | P | |
| Fetal Imaging | Adult Cephalic | | | | | | | | |
| & Other | 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 | P | P | P | | P | P | P | |
| Vessel | Other (spec.) | | | | | | | | |
Intended use Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication. P = previously cleared in K093466
* 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 Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures Subscript "a": (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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Patel
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K110623
{13}------------------------------------------------
System: Transducer:
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if 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 |
| | 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 | | | | | | | |
| Fetal Imaging<br>& Other | 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 K093466
* Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 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, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Patel
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device
510(k) Number: K110673
{14}------------------------------------------------
System:
#### Transducer EUP-CC531
| 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 | P | P | P | | P | P | P |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-rectal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | 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.) | | | | | | | |
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
N = new indication. P = previously cleared in K093466
* 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 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, penis. |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": For pediatric patients. |
| Subscript "h": Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Patel
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K110623
{15}------------------------------------------------
System: Transducer EUP-CV524
| | | Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows- |
|--|--|--------------------------------------------------------------------------------------…
