ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM

K970508 · Shimadzu Medical Systems · IYO · Aug 4, 1997 · Radiology

Device Facts

• Record ID: K970508
• Device Name: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shimadzu Medical Systems
• Product Code: IYO · Radiology
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Device Story

The SDU-2000 is a diagnostic ultrasound system utilizing various transducers (PA sector, convex, linear array) to acquire acoustic signals from the human body. The system processes these signals to generate B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, Power Doppler, and Color Velocity Imaging outputs. Operated by clinicians in a clinical setting, the device provides real-time visualization and hemodynamic analysis. Healthcare providers interpret these images and Doppler data to assist in clinical diagnosis and patient management. The system supports combined modes (e.g., B/M, B/PWD, Color/PWD) to enhance diagnostic utility. Benefits include non-invasive assessment of anatomy and blood flow.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench-level acoustic output compliance.

Technological Characteristics

Diagnostic ultrasound system supporting multiple transducer types: 2.5/3.5/5.0 MHz PA Sector, 3.5 MHz R40/R76 Convex, 7.5 MHz Linear Array, and 5.5 MHz TV Convex. Operates in B, M, PWD, CWD, Color Doppler, Power Doppler, and Color Velocity Imaging modes. Connectivity and specific software architecture are not detailed beyond standard diagnostic ultrasound signal processing.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, including abdominal, cardiac (adult/pediatric), fetal, small organ (thyroid, testicles, breast), peripheral vessel, trans-rectal, and trans-vaginal applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Yasuhuru Ishii
Manager, Ultrasound Product
Engineering and Technical Support AUG - 4 1997
Shimazu Medical Systems
20101 South Vermont Ave.
Torrence, CA 90502

Re: K970508
Echo View SDU-2000 Diagnostic Ultrasound System
Dated: June 20, 1997
Received: June 23, 1997
Regulatory class: II
21 CFR 892.1550/Procode: 90 IYO

Dear Mr. Yashuhuru:

We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SDU-2000, as described in your premarket notification:

| Transducer Model Number |
| --- |
| 2.5 MHz PA SECTOR |
| 3.5 MHz PA SECTOR |
| 5.0 MHz PA SECTOR |
| 3.5 MHz R40 CA CONVEX |
| 3.5 MHz R76 CA CONVEX |
| 7.5 MHz LA LINEAR ARRAY |
| 5.5 MHz TV CONVEX |

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic QS inspections, the Food and

{1}

Page 2 - Yasuhuru Ishii

Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the *Federal Register*. *Please note*: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for *in vitro* fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for *in vitro* fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA’s position on this use.

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 February 17, 1993 “Revised 510(k) Diagnostic Ultrasound Guidance for 1993.” 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its internet address http://www.fda.gov/cdrh/dsmamain.html”.

{2}

Page 3 - Yasuhuru Ishii

If you have any questions regarding the content of this letter, please contact Maureen Butler at [phone].

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{3}

Ultrasound Device Indications Statement Page 1 of 7

510(k) Number (if known):

Device Name : Diagnostic Ultrasound System SDU-2000, PA probe 2.5

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | X | | X | X | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | X | X | |
| Cardiac Pediatric | | X | X | X | X | X | X | X | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Other of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970508

Prescription Use (Per 21 CFR 801.109)

{4}

Ultrasound Device Indications Statement Page 2 of 7

510(k) Number (if known):

Device Name: Diagnostic Ultrasound System SDU-2000, PA probe 3.5

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | X | | X | X | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | X | X | |
| Cardiac Pediatric | | X | X | X | X | X | X | X | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

**B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode**

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970508

Prescription Use (Per 21 CFR 801.109)

{5}

Ultrasound Device Indications Statement Page 3 of 7

510(k) Number (if known): ___________________________.

Device Name: Diagnostic Ultrasound System SDU-2000, PA probe 5.0

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | X | | X | X | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | X | X | X | X | X | X | |
| Cardiac Pediatric | | X | X | X | X | X | X | X | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

**B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode**

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970508

Prescription Use (Per 21 CFR 801.109)

{6}

Ultrasound Device Indications Statement Page 4 of 7

510(k) Number (if known): ___________________________________________________________________________________________

Device Name: **Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R40**

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

**Mode of Operation**

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | X | | X | X | X | X | |
| Abdominal | | X | X | X | | X | X | X | X | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:
**B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode**

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


{7}

Ultrasound Device Indications Statement Page 5 of 7

510(k) Number (if known): _________________________
Device Name: Diagnostic Ultrasound System SDU-2000, CA probe 3.5 R76

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | X | | X | X | X | X | |
| Abdominal | | X | X | X | | X | X | X | X | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:
** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970508

Prescription Use (Per 21 CFR 801.109)

{8}

Ultrasound Device Indications Statement Page 6 of 7

510(k) Number (if known): _________________________
Device Name: Diagnostic Ultrasound System SDU-2000, LA probe 7.5 PV

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | X | X | X | | X | X | X | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | X | X | X | | X | X | X | X | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:
* Thyroid, Testicles, Breast
** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)


(Division Sign Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 1970508

{9}

Ultrasound Device Indications Statement Page 7 of 7

510(k) Number (if known): ___________________________

Device Name: Diagnostic Ultrasound System SDU-2000, TV probe 5.5 11R

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | X | | X | X | X | X | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) * | | X | X | X | | X | X | X | X | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | X | X | X | | X | X | X | X | |
| Trans-vaginal | | X | X | X | | X | X | X | X | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

** B/M, B/PWD, Color/PWD, B/PWD/M, Color/M and Color/PWD/M mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDR11, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970508

Prescription Use (Per 21 CFR 801.109)