(246 days)
Not Found
No
The provided 510(k) summary does not mention AI, ML, DNN, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The device is described as a "mobile diagnostic ultrasound system" with intended uses for "diagnostic ultrasound imaging or Doppler analysis of the human body." It is used for imaging and analysis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". Also, the "Device Description" calls it a "mobile diagnostic ultrasound system."
No
The device description explicitly states it is a "mobile diagnostic ultrasound system" with "flat linear array, convex linear and sector probe," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Description: The description clearly states the SDU-1100 is a "mobile diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures within the living body (in vivo).
- Intended Use: The intended use describes diagnostic ultrasound imaging and Doppler analysis of various parts of the human body. This is a direct imaging technique performed on the patient, not a test on a sample.
Therefore, based on the provided information, the SDU-1100 is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SDU-1100 is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Fotal, Froundiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
System SDU-1100 Indications: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
L040-075U Transducer Indications: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
L040-120U Transducer Indications: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
L040-120HU Transducer Indications: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
L070-075U Transducer Indications: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
L072-050U Transducer Indications: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Real time 3D.
VA11R-055U Transducer Indications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Real time 3D.
VA13R-035U Transducer Indications: Fetal, Abdominal, Cardiac, Real time 3D.
VA13R-050U Transducer Indications: Fetal, Abdominal, Cardiac, Real time 3D.
VA20R-035U Transducer Indications: Fetal, Abdominal, Cardiac, Real time 3D.
VA40R-035U Transducer Indications: Fetal, Abdominal, Real time 3D.
VA40R-035HU Transducer Indications: Fetal, Abdominal, Real time 3D.
VA40R-035VPU Transducer Indications: Fetal, Abdominal, Transrectal, Transvaginal, Real time 3D.
VA40R-035VNU Transducer Indications: Fetal, Abdominal, Transrectal, Transvaginal, Real time 3D.
VA57R-0375WU Transducer Indications: Fetal, Abdominal, Real time 3D.
VA57R-0375HU Transducer Indications: Fetal, Abdominal, Real time 3D.
TV11R-055U Transducer Indications: Fetal, Transrectal, Transvaginal, Real time 3D.
UB10R-065U Transducer Indications: Transrectal, Real time 3D.
EC11R-055U Transducer Indications: Fetal, Transrectal, Transvaginal, Real time 3D.
EC10R-065VPU Transducer Indications: Fetal, Transrectal, Transvaginal, Real time 3D.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The SDU-1100 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, Real time 3D mode, Color mode, or in a combination of modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial, Musculo-skeletal Conventional, Transrectal.
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Shimadzu SDU-1100 (K050510, 4/1/05)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K071291", and the text at the bottom reads "pg. 1 of 2". The handwriting is somewhat rough, but the characters are generally legible.
510(k) Summary
1.0 SUBMITTER INFORMATION
1.1 Submitter: SHIMADZU MEDICAL SYSTEMS 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869
JAHI - C. 2
içi
1.2 Contact: Don Karle
- 1.3 Date: April 25, 2007
2.0 DEVICE NAME
| 2.1 Proprietary Name: | SDU-1100 |
|---|---|
| 2.2 Common Name: | Ultrasound Imaging System |
| 2.3 Classification: | Ultrasonic Pulsed Doppler Imaging System |
| FR # 892.1550, Product Code 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System | |
| FR # 892.1560, Product Code 90-IYO | |
| Diagnostic Ultrasound Transducer | |
| FR # 892.1570, Product Code 90-ITX | |
| 2.4 Predicate Device: | Shimadzu SDU-1100 (K050510, 4/1/05) |
3.0 DEVICE DESCRIPTION
The SDU-1100 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, Real time 3D mode, Color mode, or in a combination of modes.
4.0 INTENDED USE
The SDU-1100 is intended for the following applications:
1
K071291
pg.2 of 2
Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Fotal, Froundiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
5.0 SAFETY CONSIDERATIONS
SDU-1100 has been designed to meet the following voluntary and measurement standards:
- IEC 60601-1 Safety of Medical Electric Equipment .
- 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
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.
Public Health Service
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: K071291
Trade/Device Name: Diagnostic Ultrasound System SDU-1100, 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-1100, system, as described in your premarket notification:
Transducer Model Number
| L040-075U | VA11R-055U | VA40R-035HU | TV11R-055U |
|---|---|---|---|
| L040-120U | VA13R-035U | VA40R-035VPU | UB10R-065U |
| L040-120HU | VA13R-050U | VA40R-035VNU | EC11R-055U |
| L070-075U | VA20R-035U | VA57R-0375WU | EC10R-065VPU |
| L072-050U | VA40R-035U | VA57R-0375HU |
3
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
4
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Vorpi M. When
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
.
5
Ultrasound Device Indications Statement
Page _ 1 _of_20
07/29) 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify
***) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | N |
| Abdominal | | P | P | P | | P | P | P | P | P | N |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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
Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P | P | |
| Other (Specify) | | | | | | | | | | | |
of Onerotion Mode
N= new indication; P= previously cleared by FDA; E= added under Appendix E
- 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)
Thhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Other Indications or Modes:
6
Ultrasound Device Indications Statement Page 2__ of 20
671291 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmoni
c
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-----------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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
Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P | P | |
| Other (Specify) | | | | | | | | | | | |
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)
- Thyroid, Testicles, Breast
*** Real time 3D
JWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291
7
Ultrasound Device Indications Statement
Page _3_of_20
207129 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)*** | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ
(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
Conventional | | P | P | P | | P | P | P | P | P | | |
| Musculo-skeletal
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
Jwhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
8
Ultrasound Device Indications Statement Page 4 of 20
0712al 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | N | | N | N | N | N | N | | |
| Neonatal | | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N | N | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | N | | N | N | N | N | N | | |
| Musculo-skeletal
Superficial | | N | N | N | | N | N | N | N | N | | |
| 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)
urrence of CDRH, Office of Device Evaluation (ODE)
Tzhag
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
9
Ultrasound Device Indications Statement
Page __ _ of _ 20
07129 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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
Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal
Superficial | | P | P | P | | P | P | P | P | P | |
| Others (Specify) | | | | | | | | | | | |
Mode of Overation
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
Jwha
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
10
Ultrasound Device Indications Statement Page _ 6 _ of _ 20
11.201
510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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
Conventional | P | P | P | P | | P | P | P | P | P | |
| 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:
- 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 __
11
Ultrasound Device Indications Statement
Page 7 of 20
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||||
| (Amplitude) | |||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify)** | Tissue | ||||||||||
| Harmonic | |||||||||||
| Imaging | Other | ||||||||||
| (Specify) | |||||||||||
| *** | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | N | ||
| Intra-operative | |||||||||||
| (Specify) | |||||||||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | ||
| Small Organ | |||||||||||
| (Specify) * | |||||||||||
| Neonatal | |||||||||||
| Cephalic | N | N | N | N | N | N | N | N | N | ||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | ||
| Cardiac | N | N | N | N | N | N | N | N | N | ||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Others (Specify) |
Mode of Operation
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
Thhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
12
Ultrasound Device Indications Statement
Page 8_ of _ 20
K071291 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(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:
| חוות מ י
**** | דיי מחזרחו (נוזוג ויצר ריי
/ 1733 / / Th / | September 19 to 10 to 10 to | Annual Property Ann |
|--------------------|-------------------------------------------------|----------------------------------------|---------------------|
| .
100 Book Boom | ANNUAL IN AND ANNUAL FREE A BRANCH
. | -------------------------------------- | ---- |
Whay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
13
Ultrasound Device Indications Statement Page __ of __ 20
(07/291 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dhhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
14
Ultrasound Device Indications Statement
Page 10 of __ 20 __
KD71291 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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 Oneration
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
15
Ultrasound Device Indications Statement
Page 11 20 of
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Oneration
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
DWhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
16
Ultrasound Device Indications Statement Page _ 12 _ of _ 20 _
67129 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, 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
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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:
| A-4-4-4-4-4-4-4-4-4-4
month
TYTY TTA
1/1/1/1/1/1/1/11/17 10:1/10/1/2
1 2008 11 11 11 11 11 11 11
| 1 00 Acres of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Canada Caranter Color |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------
Carlos Children Charles | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Jhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
17
Ultrasound Device Indications Statement
Page _ 13_ of __ 20
હના ટેવ 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, VA40R-035VPU
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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | | N | N | N | N | N | N |
| Abdominal | N | N | N | N | | N | N | N | N | N | N |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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
Thhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291
18
Ultrasound Device Indications Statement
Page _ 14_ of _ 20
0712a1 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, VA40R-035VNU
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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | N |
| Abdominal | | N | N | N | | N | N | N | N | N | N |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Κοτ1291
19
Ultrasound Device Indications Statement Page _ 15 _ of 20
K071291 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, VA57R-0375WU
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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Oneration
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
JWhay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
20
Ultrasound Device Indications Statement Page _ 16_of_20
(07129) 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, VA57R-0375HU
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 | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Application | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhag
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
21
Ultrasound Device Indications Statement Page 17 of 20__
Page 17 of 20.
Korizal 510(k) Number (if known) : ر
Device Name : Diagnostic Ultrasound System SDU-1100, TV11R-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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P | P | |
| Transvaginal | | P | P | P | | P | P | P | P | P | |
| 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
Jwhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291
22
Ultrasound Device Indications Statement Page _18 _of_20
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, UB10R-065U
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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P | P | |
| 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
Jwhas
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291
23
Ultrasound Device Indications Statement
Page _19_of_20
Ko71291 510(k) Number (if known) : j
Device Name : Diagnostic Ultrasound System SDU-1100, ECI 1R-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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| (Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N | N | |
| Transvaginal | | N | N | N | | N | N | N | N | N | |
| 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
JWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291
24
Ultrasound Device Indications Statement
Page 20 of 20
K071291 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1100, EC10R-065VPU
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
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify)
*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | N |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N | N | N |
| Transvaginal | | N | N | N | | N | N | N | N | N | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |
Mode of Oneration
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
JWhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __