ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
Device Facts
| Record ID | K071287 |
|---|---|
| Device Name | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO |
| Applicant | Shimadzu Medical Systems |
| Product Code | ITX · Radiology |
| Decision Date | Jan 9, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The SDU-2200Pro is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Device Story
SDU-2200Pro is a mobile diagnostic ultrasound system; utilizes flat linear array, convex linear, and sector probes (2-15 MHz). Operates in B, M, Pulsed Doppler, Continuous Doppler, Color, and Real-time 3D modes. Used in clinical settings by healthcare professionals for diagnostic imaging and Doppler analysis. System transforms acoustic echoes into visual displays; aids clinicians in anatomical visualization and blood flow assessment. Benefits include non-invasive diagnostic evaluation of various body systems.
Clinical Evidence
Bench testing only. The device complies with IEC 60601-1, UL60601-1, and AIUM/NEMA acoustic output measurement and labeling standards (UD2, UD3). No clinical data was required for this clearance.
Technological Characteristics
Mobile ultrasound system; frequency range 2-15 MHz; supports B, M, Pulsed/Continuous Doppler, Color, and 3D modes. Transducers include linear, convex, and sector arrays. Complies with IEC 60601-1, UL60601-1, and AIUM/NEMA UD2/UD3 standards. Connectivity and software details not specified beyond general diagnostic imaging functionality.
Indications for Use
Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, including fetal, abdominal, pediatric, small organs (thyroid, testicles, breast), neonatal/adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) applications.
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.
Predicate Devices
- Shimadzu SDU-2200Pro (K061637)
Related Devices
- K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO · Shimadzu Medical Systems · Jan 9, 2008
- K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO · Shimadzu Medical Systems · Jul 25, 2006
- K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO · Shimadzu Medical Systems · Jul 27, 2006
- K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 · Shimadzu Medical Systems · Jan 9, 2008
- K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 · Shimadzu Medical Systems · Apr 1, 2005
Submission Summary (Full Text)
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K071287
pg. 1 of 2
### 510(k) Summary
# 1.0 SUBMITTER INFORMATION
JAN ー 9 2008
- SHIMADZU MEDICAL SYSTEMS 1.1 Submitter: 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869
1.2 Contact: Don Karle
- 1.3 Date: April 25, 2007
#### 2.0 DEVICE NAME
| 2.1 Proprietary Name: | SDU-2200Pro |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.2 Common Name: | Ultrasound Imaging System |
| 2.3 Classification: | Ultrasonic Pulsed Doppler Imaging System<br>FR # 892.1550, Product Code 90-IYN<br>Ultrasonic Pulsed Echo Imaging System<br>FR # 892.1560, Product Code 90-IYO<br>Diagnostic Ultrasound Transducer<br>FR # 892.1570, Product Code 90-ITX |
| 2.4 Predicate Device: | Shimadzu SDU-2200Pro (K061637, Jul./25/06) |
## 3.0 DEVICE DESCRIPTION
The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.
#### 4.0 INTENDED USE
The SDU-2200Pro is intended for the following applications:
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Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
# 5.0 SAFETY CONSIDERATIONS
SDU-2200Pro has been designed to meet the following voluntary and measurement standards:
- IEC 60601-1 Safety of Medical Electric Equipment .
- UL60601-1:2003 Medical Electrical Equipment Part I : General Requirements . for Safety
- AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
- AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2008
Mr. Don Karle Manager, Customer Service Shimadzu Medical Systems USA 20101 South Vermont Avenue TORRANCE CA 90502
Re: K071287
Trade/Device Name: Diagnostic Ultrasound System SDU-2200Pro, system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 18, 2007 Received: December 19, 2007
Dear Mr. Karle:
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 Diagnostic Ultrasound System SDU-2200Pro, system, as described in your premarket notification:
#### Transducer Model Number
| L040-075U | VA13R-035U | VA40R-035VNU | EC10R-065VPU |
|------------|--------------|--------------|--------------|
| L040-120U | VA13R-050U | VA57R-0375WU | S011-050U |
| L040-120HU | VA20R-035U | VA57R-0375HU | S017-035U |
| L070-075U | VA40R-035U | TV11R-055U | S020-025U |
| L072-050U | VA40R-035HU | UB10R-065U | |
| VA11R-055U | VA40R-035VPU | EC11R-055U | |
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Norge M Whay
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
-
:
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Ultrasound Device Indications Statement
Page_1_of_23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, system
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | N |
| Abdominal | | P | P | P | | P | P | P | P | P | N |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P | P | N |
| Transvaginal | | P | P | P | | P | P | P | P | P | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P | P | |
| Other (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
| * Thyroid | Testicles | Breast |
|-----------|-----------|--------|
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Ultrasound Device Indications Statement
Page _2 _ of _ 23
K07128 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, L040-075U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmoni<br>c<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-----------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P | P | |
| Other (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
* Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
Th
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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Ultrasound Device Indications Statement
Page 3 of 23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, L040-120U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P | P | |
| Others (Specify) | | | | | | | | | | | |
Mode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
* Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thha
(Division Sign-Off) Division of Reproductive, Abdomis Radiological Devices 510(k) Number
{8}------------------------------------------------
Ultrasound Device Indications Statement
Page 4 of 23
1071287 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, L040-120HU
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<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | P | P | P | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes: * Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
(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 and
Radiological Devices
K071287
510(k) Number
{9}------------------------------------------------
Ultrasound Device Indications Statement Page _ 5__ of_ 23
107128 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, L070-075U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | P | P | P | P | | P | P | P | P | P | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | P | P | P | |
| Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
* Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
Ultrasound Device Indications Statement
Page _6__ of __23
K67128 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-2200Pro, L072-050U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
* Thyroid, Testicles, Breast
** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)
*** Real time 3D
Thha
(Division Sign-Off) Division of Reproductive. Abdominal a Radiological Devices 510(k) Number
{11}------------------------------------------------
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of _ 23 407128. 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA11R-055U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | P | P | P | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | P | P | P | | P | P | P | P | P | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | | P | P | P | P | P | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
*** Real time 3D
JWhan
(Division Sign-Off) Division of Reproductive. Abdomina Radiological Devices 510(k) Number
{12}------------------------------------------------
Ultrasound Device Indications Statement
Page_8 of 23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA13R-035U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix B
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) *** Real time 3D
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > (Division Sian-Off) Division of Reproductive. Abdominat Radiological Devices 510(k) Number
{13}------------------------------------------------
Ultrasound Device Indications Statement
Page 9 of 23
10-11-28 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA13R-050U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify)* | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) *** Real time 3D
**Real time 3D**
JWhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{14}------------------------------------------------
Ultrasound Device Indications Statement
Page _10_ of _ 23
K01128 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA20R-035U
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:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** | |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | | |
| Abdominal | | P | P | P | | P | P | P | P | P | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | | |
| Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Conventional | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) *** Real time 3D
\$\mathcal{R}h\$
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
{15}------------------------------------------------
Ultrasound Device Indications Statement
Page_11_of_23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA40R-035U
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<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
| ** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) |
|-----------------------------------------|
| *** Real time 3D |
TWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{16}------------------------------------------------
Ultrasound Device Indications Statement
Page _ 12_ of _ 23
1121128 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA40R-035HU
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:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |…
