(246 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound modes.
No.
The intended use explicitly states "Diagnostic ultrasound imaging or Doppler analysis," indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". The "Device Description" also refers to it as 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The SDU-1200Pro is described as a "mobile diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or Doppler analysis of the human body." This refers to imaging the body directly, not analyzing samples.
Therefore, the SDU-1200Pro falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SDU-1200Pro 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous 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, Musculo-skeletal (Superficial and Conventional), Transrectal.
Indicated Patient Age Range
Pediatric, Neonatal, Adult
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-1200Pro (K061643, Jul./27/06)
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
K071289
pg. 1 of 2
JAN
!
9 2008
510(k) Summary
1.0 SUBMITTER INFORMATION
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-1200Pro |
|---|---|
| 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-1200Pro (K061643, Jul./27/06) |
3.0 DEVICE DESCRIPTION
The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
4.0 INTENDED USE
The SDU-1200Pro is intended for the following applications:
1
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-1200Pro 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
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with a serpent entwined around it.
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: K071289
Trade/Device Name: Diagnostic Ultrasound System SDU-1200Pro, 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-1200Pro, 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 |
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 (OS) 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,
Noyn Th Whay
Gr Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
.
Enclosure(s)
1
5
Ultrasound Device Indications Statement Page 1 of 23
K071289 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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) | | | | | | | | | | | |
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
6
Ultrasound Device Indications Statement Page 2 of _ 23
071280 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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) | | | | | | | | | | | |
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)
JWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Division of Reproductive, Abdomina Radiological Devices 510(k) Number
7
Ultrasound Device Indications Statement
Page 3 of 23
011289 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 | 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 | P | 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
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289
8
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4 of 23
K071289 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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) * | | 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
Thang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
9
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 23
K071289 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 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
TWhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
10
Ultrasound Device Indications Statement
Page 6 of 23
510(k) Number (if known) : k 071284
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | 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:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jwhg
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
11
Ultrasound Device Indications Statement
Page 7 of 23
011280 510(k) Number (if known) : _ Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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
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 | | P | P | P | | P | P | P | P | P | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | P | P | P | | P | P | P | P | P | |
| 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
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 K071289
12
Ultrasound Device Indications Statement
Page _ _ of 23
K611289 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 | |
| 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:
| 13.7 | 1/1 / 1 / 1 / 1 / 1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /
1
. | Carrent A A dentify of | | A Property & Annual Property on Children Comments on Children Charges of Children Children Children Children Children Children Children Children Children Children Children Ch | |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BOOK HOTEL IN
Carl Property
Accoments of call and the first for the | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AN AN AND AND LEAN LEAN LE BEAR ALL BEAULA E E LEASE IL E LEASE IL E LEASE IL PARA
LAND AN AN | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Children & Concession Company Company Comprehens Company College Company College Company College Company College Company Concess of Concession Compares of Concession
Company Acres of American Company Co. A coll come considere for the first for the | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MALA BLACK |
Shhy
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K011289
13
Ultrasound Device Indications Statement
Page_9__ of_23
671289 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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) | | | | | | | | | | | |
| 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:
| A Chicago Child Call Child La
חוזה לחזות מ
| 100 100 |
|---|
| 11 10 10 10 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 |
| STATIS AND A . A |
| Acres of alle |
| 1 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
- Children Channel | LANDREAL AND A |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
als and alle
10 84 | A MIN AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND
I | | | . | - 4 4 4 -- 4 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 -- 4 | |
| I | | | | | | |
(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 510(k) Number
14
.
Ultrasound Device Indications Statement Page 10 _of_23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
|
No. of Canadian
1
200 000
1
Freener of the Research and Children of Children of Children
Carolina College of Children
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | I
1 - - - -
A Property of Concession Charles Charles Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childre
Clinia J / Th / / Th ST Try
100 : 00 : 000
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School An Allery An
1 | 10-06-06-4
1000 AM And |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | Book And And And Children Company
And Charles of Children Children
1
------------- | |
JWhing
(Division Sign-Off ductive, Abdominal and Division of F Radiologica 510(k) Numbe
15
Ultrasound Device Indications Statement Page __ 11_ of _23
Page 11 of 23
510(k) Number (if known) :
Device Name : Djagnostic Ultrasound System SDU-1200Pro, 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 Operation
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
LA SECREEMENT COLLEGE COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONNOME CARD
SI IN LEASE SHOW SHOULD SECTION COLLECT
** R/M R/PWD CRM/R/PWD CFM/R/CFM/A/ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| 2-45 1-84 4-4
Page Part Part
.
A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A A | A 400 - 400 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - | |
| A . A . A . A | | A MIN AR |
(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 510(k) Number
16
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _12 of __23 011280 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 | |
| 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:
| ** DA
דז דאח/ דו
CFM/R/PWD CEMB/CEM
| 1 | |
|---|---|
| School Station And Advertising College of Children | |
| Canada Children American Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company o | |
| 1 | |
| A PAGE A CALL CONTRACTOR COLLEGION |
Beach Auto
and and see
1999 C
Carrer
|
Bearing Late & Life |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal Radiological Devices 510(k) Number
17
Prescription Use (Per 21 CFR 801.109)
Ultrasound Device Indications Statement Page 13 of 23
| 510(k) Number (if known): | K071289 |
|---|---|
| --------------------------- | --------- |
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 |
| 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:
| | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 |
|---------|-------------------------------------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ** B/M. | .A. B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) | | |
| | | 1 | |
*** Real time 3D
(Division Sign-Off) swhay
Division of Reproductive, Abdominal and
Radiological Devices
Radiological Devices
510(k) Number K07
18
Ultrasound Device Indications Statement
Page 14 of _ 23
0-11-28 510(k) Number (if known) : __
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 Oneration
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Other Indications or Modes:
| The was read to the state of the states of the country of the country of the first and the county of the first of the first of the first and the first and the first and the f
D /DITTY
| -------------------------------------------------------------------------------- | ווייץ מקומע מעני מענעמעס ומעני |
|---|---|
| ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | |
| . | |
| --------------------------------------------------------------------------------- | ------ |
| ANNUAL CO. MI AND AN AND AN AND OF ANT | |
| B LENGLE CONSULER |
- |
(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, Abdominal a Radiological Devices 510(k) Number
JWhay
19
Ultrasound Device Indications Statement
Page __ 15_ of __ 23
011280 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 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(B)/CFM(M) | |
|---|---|
| A montal de from the first for the first for the count of the country of the comments of the | |
| The The The Court of Children Collection of the Collection Controlled of the Children | |
| ריר - - - - - 1 -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
** Real time 3D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
JWhang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
20
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_16_of_23
510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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
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:
|
** D Л /
The IT: TT: 1 The 1 The 1 The 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
יווי ליינו והיות וחד מחוז גודות מחול
A ARABLE
CONTRACTOR COLLEGION COLLEGION
Address of the contribution of the company of the company of the company of the company of the company of the company of the company of the company of the company of the comp |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| 1000 110 100 |
|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| All add to |
| 100% 100% |
| Company of Children |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | o
THE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| 1 |
|---|
(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 a Radiological Devices 510(k) Number
21
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 17 of 23 1280 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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
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
22
Ultrasound Device Indications Statement
Page 18 of 23
510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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 | 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
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289
23
Ultrasound Device Indications Statement
Page 19 of 23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, EC11R-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:
| -----------------
44 T. 12 8
מיני מוני 1
A
A Children
Character Concession Call Cr. A 800 A 800 A 800 A 8000 A 8000 A 8000 A 8000 A 800 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ANNUAL A CANADA MARK A BELL A CO |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 - 1 - 1 -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Address Company Controllers of
Amade
STATISTIC OF ACREEN OF CONSULTION OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH A
Address of Address And |
| commended to be annual a common of consideration of the
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------- |
(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 ar Radiological Devices 510(k) Number
24
Ultrasound Device Indications Statement
Page 20 of 23
071289 510(k) Number (if known) : _
Device Name : Diagnostic Ultrasound System SDU-1200Pro, 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:
| 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 | |||||||||||
| 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:
| ------
- The Trial The Free States of American Comments of American Comments of American Comments of American Comments of American Comments of American Come of Comments of American
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100 - All All - All - All - Children - Charles - Charles - Career - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracte | 1 4 40
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1
AND A CONSULTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONTRACTOR COLLEGION CONTRA | | -------------- | SAR-LA-LA-A-A-
Company Company CAS A Change Cat | AN - AN - Click 4 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------|-------------------|--|
| CARLAND COLLECTION
| | CALLERY
A Property of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childre | . | MARRA A LA PERSON | -
---------- | |
| Company of Children Company of Children | Not and any annual resume of
|
I | -------------------------- | | . | |
(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 a Radiological Devices 510(k) Number
25
Ultrasound Device Indications Statement
Page 21 of _ 23
117 KC 510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, S011-050U
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 | | | | P | | P | P | | | P | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | 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)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD
Harmonic Imaging *** 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
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289
26
Ultrasound Device Indications Statement
Page 22 of _23
510(k) Number (if known) :
Device Name : Diagnostic Ultrasound System SDU-1200Pro, S017-035U
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 | | | | | | | | | | | | |
| Abdominal | | | | 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 | 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)/PWD |
| CFM(B)/CFM(M) | B/CWD |
| CFM(B)/CWD |
Harmonic Imaging *** Real time 3D
JWhang
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
27
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_23_of 23 671780
510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, S020-025U
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 | | | | 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 | 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)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD
Harmonic Imaging
*** Real time 3D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DWhan
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number