MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
Device Facts
| Record ID | K013723 |
|---|---|
| Device Name | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
| Applicant | Hitachi Medical Corp. |
| Product Code | ITX · Radiology |
| Decision Date | Feb 6, 2002 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Device Story
The Hitachi EUB-6500 is a Track 3 diagnostic ultrasound system. It processes acoustic signals from various transducers to generate B-mode, M-mode, Pulsed Doppler, Continuous Wave Doppler, and Color Flow (including Amplitude Doppler) images. It also supports harmonic imaging and 3D imaging. Used in clinical settings by physicians and trained sonographers, the device provides real-time visual feedback for diagnostic assessment and interventional guidance (e.g., biopsies). The system displays thermal and mechanical acoustic output indices per NEMA UD-3 standards to ensure patient safety. Clinicians use the output to visualize internal structures, assess blood flow, and guide procedures, facilitating diagnosis and treatment planning.
Clinical Evidence
Bench testing only. The device complies with NEMA UD-3 standards for real-time display of thermal and mechanical acoustic output indices and the April 14, 1994, FDA guidance for diagnostic ultrasound systems. No clinical data was required for this clearance.
Technological Characteristics
Diagnostic ultrasound system supporting B, M, Pulsed Doppler, Continuous Wave Doppler, Color Flow, Amplitude Doppler, harmonic imaging, and 3D imaging. Complies with IEC 60601-1 (1998) for electrical safety and NEMA UD-3 (1992) for acoustic output. Compatible with multiple transducer models (e.g., EUP-B314, EUP-C514, EUP-L54M).
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intra-operative, pediatric, small organ (thyroid, parathyroid, breast, scrotum, penis), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Includes guidance for percutaneous biopsy of abdominal organs, amniocentesis, and transrectal/transvaginal biopsies.
Regulatory Classification
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Submission Summary (Full Text)
{0}------------------------------------------------
# FEB 0 6 2002
### SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-6500 Diagnostic Ultrasound Scanner
#### Device Description
The Hitachi EUB-6500 Diagnostic Ultrasound Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
#### Safety
As a Track 3 ultrasound device, the Hitachi EUB-6500 Diagnostic Ultrasound Scanner complies with the "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992)", published by NEMA as UD-3. With respect to limits on acoustic outputs, the Hitachi EUB-6500 Diagnostic Ultrasound Scanner complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the Hitachi EUB-6500 Diagnostic Ultrasound Scanner is designed to comply with IEC 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird or a person reaching out, with three curved lines forming the body and arm. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## FEB 0 6 2002
Mr. Walter Weyburne Regulatory Affairs Hitachi Medical Corporation of America 660 White Plains Road TARRYTOWN NY 10591
Re: K013723
Trade Name: EUB-6500 Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic transducer Product Code: 90 ITX Regulatory Class: II Dated: January 24, 2002 Received: January 25, 2002
Dear Mr. Weyburne:
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 (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). 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 EUB-6500 Diagnostic Ultrasonic Scanner, as described in your premarket notification:
{2}------------------------------------------------
#### Transducer Model Number
EUP-B314 EUP-C514 EUP-ES322 EUP-ESS2M EUP-ES533 EUP-F531 EUP-L54M EUP-L53S EUP-OL334 EUP-R53W EUP-S50 EUP-TC3 EUP-U533 EUP-VS3W
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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
{3}------------------------------------------------
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 nothleation. THE PDF Intention for your 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 If you tester of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the notification (2) Stained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David a. Leipson
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
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 | N | N | N | N | N | N | N | |
| | Abdominal | Na | Na | Na | Na | Na | Na | Na | |
| | Intra-operative (Spec.) | Nb | Nb | Nb | Nb | Nb | Nb | Nb | |
| | Intra-operative (Neuro.) | N | N | N | N | N | N | N | |
| | Laparoscopic | N | N | N | | N | N | N | |
| | Pediatric | N | N | N | N | N | N | N | |
| | Small Organ (Spec.) | Nd | Nd | Nd | | Nd | Nd | Nd | |
| | Neonatal Cephalic | N | N | N | | N | N | N | |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N | |
| | Trans-rectal | Nh | Nh | Nh | | Nh | Nh | Nh | |
| | Trans-vaginal | Nf | Nf | Nf | | Nf | Nf | Nf | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | N | N | |
| | Musculo-skel. (Superfic.) | N | N | N | | N | N | N | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | |
| | Trans-esophageal (card.) | Ng | Ng | Ng | | Ng | Ng | Ng | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N | |
| | Other (spec.) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 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<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. |
**Subscript "b":** 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)
Vorin G. Kynn
Minister of Finance
(Division Sign Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K122015
Prescription Use (Per 21 CFR 801.109)
Section 4.3 Page 1 / 15
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System: Transducer:
#### EUB-6500 EUP-B314
#### 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 | N | N | N | | N | N | N |
| | Abdominal | Na | Na | Na | | Na | Na | Na |
| | Intra-operative (Spec.) | Nb | Nb | Nb | | Nb | Nb | Nb |
| | 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.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 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<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. |
script. D. Includes masking for guidance of anatomical display.
PLEASE DO NOT WRITE BELOW THIS LINE. FOR MITTEE ON ALL NOTES.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Heyman
Division Sign (4a)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:***_***
Prescription Use (Per 21 CFR 801.109)
Section 4.3 Page 2 / 15
{6}------------------------------------------------
System: Transducer:
EUP-C514
EUB-6500
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 | | | | | | | N | |
| | Fetal | N | N | N | | N | N | N | |
| | Abdominal | Na | Na | Na | | Na | Na | Na | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | |
| | Small Organ (Spec.) | Nd | Nd | Nd | | Nd | Nd | Nd | |
| | 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 | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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. |
( LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{7}------------------------------------------------
System: Transducer:
#### EUB-6500 EUP-ES322
College of the product and the production of the
#### 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 | | | | | | | |
| | Abdominal | | | | | | | |
| | 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.) | N | N | N | N | N | N | N |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler and 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)
Emin A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{8}------------------------------------------------
System: Transducer: EUB-6500
EUP-ES52M
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis it the human body as follows:
Mode of Operation Clinical Application Other ** Combined* Color CAMD PWD B M Specific General (Spec.) (Spec.) Doppler (Tracks I & III) (Track I only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Spec.) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (Spec.) Neonatal Cephalic Adult Cephalic Fetal Imaging Trans-rectal & Other Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Pediatric Cardiac N N N N N N N Trans-esophageal (card.) Other (spec.) Peripheral vessel Peripheral Other (spec.) Vessel
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| 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 N Concurrence of CDRH, Office of Device Evaluation (ODE)
Cl. J. de Jong
David G. Wegner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{9}------------------------------------------------
System: Transducer:
#### EUB-6500 EUP-ES533
#### 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 | | | | | | | |
| | Abdominal | | | | | | | |
| | 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.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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)
David A. Segerson
(Division Sign-off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{10}------------------------------------------------
System: Transducer: EUB-6500
EUP-F531
## 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 | N | N | N | N | N | N | N | |
| | Abdominal | Nb | Nb | Nb | Nb | Nb | Nb | Nb | |
| | Intra-operative (Spec.) | N | N | N | N | N | N | N | |
| | Intra-operative (Neuro.) | N | N | N | N | N | N | N | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | |
| | Small Organ (Spec.) | Nc | Nc | Nc | Nc | Nc | Nc | Nc | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | N | |
| | Trans-vaginal | N | N | N | N | N | N | N | |
| | 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 | N | N | N | N | N | N | N | |
| | Other (spec.) | | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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. |
Subscr
(PLEASE DO NOT WRITE BELOW THIS MINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Emil A. Hegner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{11}------------------------------------------------
System: Transducer: EUB-6500
EUP-L54M
## 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 | | | | | | | | |
| | | Abdominal | Na | Na | Na | | Na | Na | Na | |
| | | Intra-operative (Spec.) | | | | | | | | |
| | | Intra-operative (Neuro.) | N | N | N | | N | N | N | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | N | N | N | | N | N | N | |
| | | Small Organ (Spec.) | Nd | Nd | Nd | | Nd | Nd | Nd | |
| | | Neonatal Cephalic | | | | | | | | |
| | Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | | |
| | | Musculo-skel. (Convent.) | N | N | N | | N | N | N | |
| | | Musculo-skel. (Superfic.) | N | N | N | | N | N | N | |
| | | Intra-luminal | | | | | | | | |
| | | Other (spec.) | | | | | | | | |
| | Cardiac | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | |
| | | Trans-esophageal (card.) | | | | | | | | |
| | | Other (spec.) | | | | | | | | |
| | Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N | |
| | | Other (spec.) | | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 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. |
Includes imaging for guidance of transrectal biopsy. Subscript "h": (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
✓
Prescription Use (Pcr 21 CFR 801.109)
{12}------------------------------------------------
System: Transducer: EUB-6500
EUP-L53S
#### 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 | | | | | | | | | |
| | Abdominal | Na | Na | Na | | Na | Na | Na | | |
| | Intra-operative (Spec.) | | | | | | | | | |
| | Intra-operative (Neuro.) | N | N | N | | N | N | N | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | | |
| | Small Organ (Spec.) | Nd | Nd | Nd | | Nd | Nd | Nd | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | N | N | | |
| | Musculo-skel. (Superfic.) | N | N | N | | N | N | N | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | N | | |
| | Other (spec.) | | | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| Additional Comments. | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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)
David G. Hyman
---
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number:
{13}------------------------------------------------
System: Transducer:
#### EUB-6500 EUP-OL334
### Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Mode of Operation Clinical Application PWD CNTD Color Combined* Other* M General Specific B (Spec.) Doppler (Spec.) (Track I only) (Tracks I & III) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Spec.) Intra-operative (Neuro.) N N N N Laparoscopic N N Pediatric 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 Adult Cardiac Pediatric Cardiac Trans-esophageal (card.) Other (spec.) Peripheral vessel Peripheral Other (spec.) Vessel
N = new indication.
* Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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. |
છે, જ
Subscript "e": Includes imaging for guidance of transrectal biopsy. Subscript "f": Includes imaging for guidance of transvaginal biopsy. Subscript "g": For pediatric patients.
Includes imaging for guidance of transrectal biopsy Subscript "h":
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymann
(Division Sign-Qff) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number: K161613
Prescription Use (Per 21 CFR 801.109)
Section 4.3 Page 10 / 15
{14}------------------------------------------------
System: Transducer: EUB-6500
EUP-R53W
### 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 Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | |
| | 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.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler and 3D Imaging.
#### Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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)
David Li. Mason
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K033023
\/
**Prescription Use (Per 21 CFR 801.109)**
Section 4.3 Page 11 / 15
{15}------------------------------------------------
System: Transducer:
#### EUB-6500 EUP-850
## 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 | N | N | N | N | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| | Other (spec.) | | | | | | | |
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(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 NEEDEDY
COLORIES Concurrence of CDRH, Office of Device Evaluation (ODE)
**Concurrence of CDRH, Office of Device Evaluation (ODE)**
David A. Larson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K013533
Prescription Use (Per 21 CFR 801.109)
{16}------------------------------------------------
System: Transducer:
EUB-6500 EUP-TC3
### 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 | | | | | | | |
| | Abdominal | | | | | | | |
| | 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 | | | | N | | | |
| | Cardiac Pediatric | | | | N | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel…
