EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
Device Facts
| Record ID | K032503 |
|---|---|
| Device Name | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER |
| Applicant | Hitachi Medical Systems America, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 22, 2003 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
Device Story
The Hitachi EUB-5500 is a Track 3 diagnostic ultrasound system providing B-mode, M-mode, Pulsed Doppler (PWD/CWD), Color Flow, Amplitude Doppler, Harmonic Imaging, and 3D imaging. It processes acoustic echoes to generate real-time images for clinical diagnosis. Used in clinical settings by trained healthcare professionals, the system supports various transducers for specific anatomical applications, including guidance for percutaneous, transrectal, transvaginal, and trans-perineal biopsies. Output is displayed on the system monitor for clinician interpretation to guide diagnostic decisions and interventional procedures. The device complies with NEMA UD-3 standards for thermal and mechanical indices and IEC 60601-1 for electrical safety.
Clinical Evidence
Bench testing only. The device complies with the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices (NEMA UD-3) and the 510(k) Diagnostic Ultrasound Guidance (1994). No clinical data was required for this clearance.
Technological Characteristics
Track 3 diagnostic ultrasound system. Supports B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Harmonic, and 3D imaging. Complies with IEC 60601-1 (1998) and NEMA UD-3 (1992). Includes various transducers (e.g., EUP-B514, EUP-C514, EUP-L53S).
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, cardiac, and peripheral vessel applications. Contraindications include neurosurgery and laparoscopic procedures for specific intra-operative applications.
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.
Related Devices
- K013723 — MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Medical Corp. · Feb 6, 2002
- K013722 — MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Medical Corp. · Feb 11, 2002
- K061608 — MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER · Hitachi Medical Corp. · Nov 22, 2006
- K954220 — EUB-8000 · Hitachi Medical Corp. of America · May 7, 1997
- K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER · Hitachi Medical Corp. of America · Mar 29, 2000
Submission Summary (Full Text)
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AUG 2 2 2003
Image /page/0/Picture/1 description: The image shows the text "K032503" in a handwritten style. The text appears to be a code or identifier, with a combination of letters and numbers. The characters are written in black ink on a white background, and the handwriting is somewhat stylized.
Summary of Safety and Effectiveness
DEED OF TRUST, SECURITY AGREEMENT, ASSIGNMENT OF RENTS AND FIXTURE FILING
# Device Description
The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions:
- B Mode .
- M Mode .
- . Pulsed Doppler
-
- . Continuous Wave Doppler
- . Color Flow ● 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-5500 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-5500 Diagnostic Ultrasound Scanner complies with the guideline limits set in the 510(k) Diagnostic Ultrasound Guidance - Revision: April 14, 1994.
With reaard to general safety, the Hitachi EUB-5500 Diagnostic Ultrasound Scanner is designed to comply with IEC 606601-1 (1998) Medical Electrical Equipment, Part 1 - General Requirements for Safety.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The image is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2003
Hitachi Medical Corporation % Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K032503
Trade Name: Hitachi EUB-5500 Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: August 6, 2003 Received: August 13, 2003
Dear Mr. Thistlewaite:
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 Hitachi EUB-5500 Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
| EUP-B514 |
|-----------|
| EUP-C514 |
| EUP-C532 |
| EUP-ES52M |
{2}------------------------------------------------
Page 2 - Mr. Thistlewaite
EUP-F531
EUP-L53S
EUP-L54M
EUP-053T
EUP-OL334
EUP-R54A-19
EUP-S50
EUP-TC3
EUP-U533
EUP-V53W
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
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 your device and thus permits your device to proceed to market.
{3}------------------------------------------------
#### Page 3 - Mr. Thistlewaite
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office 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 Act may be obtained 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,
Daniel A. Gezomm
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:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Comments of the contraction for a free a friend proposations of the controlled in the controlled | | | Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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,b | Na,b | Na,b | N | Na,b | Na,b | Na,b |
| | Intra-operative (Spec.) | Nc,d | Nc,d | Nc,d | | Nc,d | Nc,d | Nc,d |
| | Intra-operative (Neuro.) | 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,e | Nd,e | Nd,e | | Nd,e | Nd,e | Nd,e |
| | Neonatal Cephalic | N | N | N | | N | N | N |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | Nf,h | Nf,h | Nf,h | | Nf,h | Nf,h | Nf,h |
| | Trans-vaginal | Ng | Ng | Ng | | Ng | Ng | Ng |
| | 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 | N | N | N | N | N | N | N |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esophageal (card.) | N | N | N | | N | N | N |
| | 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 |
|----------------|-------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures |
| | (including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery |
| | (excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Vinit A. Segerson
---
(Division Sign Off)
(Division S Division of Reproductive, Abdominal, F and Radiological Devices
510(k) Number: K0322563
{5}------------------------------------------------
System: Transducer:
#### EUB-5500 EUP-B514
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|---------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | Nb | Nb | Nb | | Nb | Nb | Nb |
| | Intra-operative (Spec.) | Nc | Nc | Nc | | Nc | Nc | Nc |
| | 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 |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorid A. Sygnor
(Division Sign Off)
Division of Reproductive, Abdominal, B and Radiological Device
510(k) Number:
{6}------------------------------------------------
System: Transducer:
EUB-5500 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 | N | N | N | | N | N | N |
| | Abdominal | Nb | Nb | Nb | | Nb | Nb | Nb |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N |
| | Small Organ (Spec.) | Ne | Ne | Ne | | Ne | Ne | Ne |
| | 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, Harmonic Imaging and 3D Imaging.
Additional Comments:
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures | | | | | |
|----------------|-------------------------------------------------------------------------------------------|--|--|--|--|--|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures | | | | | |
| | (including amniocentesis). | | | | | |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery | | | | | |
| | (excluding neurosurgery and laparoscopic procedures). | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. | | | | | |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. | | | | | |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. | | | | | |
| | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legunn
(Division Sign Off)
(Division Sign-Q Division of Reproductive, Abdominal, EA and Radiological Devices
510(k) Number:
{7}------------------------------------------------
System: Transducer:
EUB-5500 EUP-C532
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------|---------------------------|----|-------------------|-----|-----|---------|-----------|---------|--|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other** | |
| (Track I only) | (Tracks I & III) | | | | | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | |
| | Intra-operative (Spec.) | N | N | N | | N | N | N | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | 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 | 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 | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | N | |
| 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 |
|----------------|--------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures |
| | (including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery |
| | (excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Heyman
(Division Sign-Q Division of Reproductive, Abdominal. BA and Radiological Devices
510(k) Number: K052503
{8}------------------------------------------------
System: Transducer:
#### EUP-ES52M
EUB-5500
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 | | | | | | | |
| | 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.) | 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 |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division Sign-off)
Division of Reproductive, Abdominal, Ca and Radiological Devices
510(k) Number:
{9}------------------------------------------------
System: EUB-2500 Transducer: 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 | | | | | | | |
| | Abdominal | N | N | N | | N | N | N |
| | Intra-operative (Spec.) | Nc | Nc | Nc | | Nc | Nc | Nc |
| | 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 | N | N | N | | N | N | N |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N |
| | Trans-vaginal | N | N | N | | N | N | N |
| | 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 | N | N | N | | N | N | N |
| 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 |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Syzonn
(Division Sign-Oll) Division of Reproductive, Abdominal. EA and Radiological Devices
510(k) Number: K0225
{10}------------------------------------------------
EUB-5500 System: Transducer: 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 | Nb | Nb | Nb | | Nb | Nb | Nb |
| | Intra-operative (Spec.) | Nc | Nc | Nc | | Nc | Nc | Nc |
| | Intra-operative (Neuro.) | N | N | N | | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N |
| | Small Organ (Spec.) | Ne | Ne | Ne | | Ne | Ne | Ne |
| | 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 |
|----------------|------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David L. Ingram
(Division Sign-0 Division of Reproductive, Abdominal. EN and Radiological Devices
510(k) Number: K132503
{11}------------------------------------------------
EUB-5500 System: Transducer: 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.) | Nc | Nc | Nc | | Nc | Nc | Nc |
| | 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 |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Legum
(Division Sign-Off Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number: K032503
{12}------------------------------------------------
T
EUB-5500 System: EUP-053T Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Intended use: Diagnostic ultrasound imaging of 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.) | Nc | Nc | Nc | | Nc | Nc | Nc | |
| | 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:
| Additional Comments: | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures |
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David h. Syrom
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number: K032503
{13}------------------------------------------------
System: Transducer:
#### EUB-5500 EUP-OL334
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 | N | N | N | | N | N | N |
| | 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 | 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 |
|----------------|-------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures |
| | (including amniocentesis). |
| Subscript "c": | Includes imaging of organs and structures exposed during surgery |
| | (excluding neurosurgery and laparoscopic procedures). |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "h": | Includes imaging for guidance of trans-perineal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel A. Szyman
(Division Sign-Off)
Division of Reproductive, Abdominal, EA and Radiological Devices
510(k) Number: K032503
{14}------------------------------------------------
1
EUB-5500 System: EUP-R54A-19 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 | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Other | 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.) | | | | | | | | |
| | 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 | | | | | |
|----------------|-------------------------------------------------------------------------------------------|--|--|--|--|--|
| Subscript "b": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures | | | | | |
| | (including amniocentesis). | | | | | |
| Subscript "c": | Includes imaging of organs and structures exposed during surgerv | | | | | |
| | (excluding neurosurgery and laparoscopic procedures). | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | |
| Subscript "e": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | |
| Subscript "f": | Includes imaging for guidance of transrectal biopsy. | | | | | |
| Subscript "g": | Includes imaging for guidance of transvaginal biopsy. | | | | | |
| | Subscript "h": Includes imaging for guidance of trans-perineal biopsy. | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number: K022503
{15}------------------------------------------------
| System: | EUB-5500 |
|-------------|----------|
| Transducer: | EUP-S50 |
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis i…
