(45 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML algorithms in medical imaging.
No
The device is described as a "Diagnostic ultrasound imaging or Doppler analysis" system and a "mobile diagnostic ultrasound system," with no mention of therapeutic applications.
Yes
The 'Intended Use / Indications for Use' 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 function: The SDU-1200Pro is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or Doppler analysis of the human body," which aligns with in vivo imaging, not in vitro testing of samples.
Therefore, the SDU-1200Pro is a medical device used for diagnostic imaging, but it does not fall under the category of 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, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Clinical Application / Mode of Operation:
Fetal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Abdominal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Pediatric: Not Found
Small Organ (Thyroid, Testicles, Breast): B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Neonatal Cephalic: Not Found
Adult Cephalic: Not Found
Cardiac: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Transvaginal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Peripheral Vascular: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Musculo-skeletal Conventional: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Musculo-skeletal Superficial: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
Transrectal: B, M, PWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)), Tissue Harmonic Imaging
For specific transducers:
L040-120U: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial
L040-120HU: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial
L070-075U: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial
L072-050U: Small Organ (Thyroid, Testicles, Breast), Peripheral Vascular, Musculo-skeletal Conventional
VA11R-055U: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac
VA13R-035U: Fetal, Abdominal, Cardiac
VA13R-050U: Fetal, Abdominal, Cardiac
VA20R-035U: Fetal, Abdominal, Cardiac
VA40R-035U: Fetal, Abdominal
VA40R-035HU: Fetal, Abdominal
VA57R-0375WU: Fetal, Abdominal
VA57R-035HU: Fetal, Abdominal
TV11R-055U: Fetal, Transrectal, Transvaginal
UB10R-065U: Transrectal
EC11R-055U: Fetal, Transrectal, Transvaginal
S011-050U: Abdominal, Pediatric, Cardiac
S017-035U: Abdominal, Cardiac
S020-025U: Abdominal, Cardiac
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, IYN, IYO, 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, 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
Not Found
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-2200 (K003514, Feb./12/01)
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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
1.2 Contact: Randal Walker
MAR. 1 7.2006 1.3 Date:
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-2200 (K003514, Feb./12/01) |
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, 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, Muscular, 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an eagle or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2006
Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
Re: K061643
Trade Name: SDU-1200Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 89.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 17, 2006 Received: June 13, 2006
Dear Mr. Walker:
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 SDU-1200Pro Diagnostic Ultrasound System, as described in your premarket notification:
Image /page/2/Picture/11 description: The image is a circular logo with the letters "FDA" in the center. The letters are stylized and bold. Above the letters "FDA" are the letters "Est. 1906". Below the letters "FDA" is the word "Centennial". The logo is surrounded by a dotted border.
Jing Puttic . Health
3
Transducer Model Number
| L040-075U | VA13R-050U | UB10R-065U |
|---|---|---|
| L040-120U | VA20R-035U | EC11R-055U |
| L040-120HU | VA40R-035U | S011-050U |
| L070-075U | VA40R-035HU | S017-035U |
| L072-050U | VA57R-0375WU | S020-025U |
| VA11R-055U | VA57R-035HU | |
| VA13R-035U | TV11R-055U |
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
4
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
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours.
Nancy C Bugdon
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
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 | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | N | | N | N | N | N | N | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | N | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N | N | |
| Transvaginal | | N | N | N | | N | N | N | N | N | |
| 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 | |
| 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)
Prescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643
6
Ultrasound Device Indications Statement Page 2 _of_20
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
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) * | | 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 | |
| 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cscription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643
7
Ultrasound Device Indications Statement Page 3 of _ 20
510(k) Number (if known) : _ 上 ひん 1 6 43
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) * | N | 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Y. Marquez
(Division Sign-Off)
Division of Reproductive, Abdominal, and Padiological Devices 5 13(x) Number _______________________________________________________________________________________________________________________________________________________________
8
Ultrasound Device Indications Statement Page _4 of_20
510(k) Number (if known) : _ 1 0 6 l 6 4 3 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:
| 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 | |||||||||||
| 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) |
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)
prescription Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K061643
9
Ultrasound Device Indications Statement Page_5 of 20
6061643 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) * | | 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)
REVISED FINAL
V. Larry C. Bearden
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 51(Xk) Number
10
Ultrasound Device Indications Statement Page_6 of 20
K061643 510(k) Number (if known) : 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) * | N | N | 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 | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | N | N | N | N | N | N | N | N | N | N | |
| 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)
Janay Prather
(Division Sign-Off) Division of Reproductive, Abdominal, and Padiological Devices 51 (1) Number
11
Ultrasound Device Indications Statement Page _7 _of 20
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
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 | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N | N | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | N | N | N | | N | N | N | N | N | |
| Adult Cephalic | | N | N | N | | N | N | N | N | N | |
| Cardiac | | 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 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)
$\checkmark$
Trusion Sign-Off & Reproductive, A olonica Devi 11 81 17100
12
Ultrasound Device Indications Statement Page_8 20 of
12061643 510(k) Number (if known) : _ Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA13K-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 | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | N | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
V
Yancy C. Morgan
on of Reproductive. Abdominal P ... Choose Device
: : : : : : :
13
Ultrasound Device Indications Statement Page 9 20 of
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 | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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
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)
7 Nancy C. Beaton
Sign-Off
f Reproductive, Abdominal,
Radiological Devices K061643
Number
14
Ultrasound Device Indications Statement Page_10 of 20
12061643 510(k) Number (if known) : _
5 Fo(x) Namber (1) laromic 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 | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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
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)
Nancy C. Ferguson
(Person Sign Off)
(Person's Legal Name - Terminal
Employee ID: 406643
15
Ultrasound Device Indications Statement Page _ 1 l of 20
KO61643 510(k) Number (if known) : _ Device Name : Diagnostic 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:
| 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 | |||
| Abdominal | 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)
J Dwayne Heaton
Division Sign-Off
Division Sign-Off)
L
Dusien af Reproductive, Abdominal,
٠٩٤٠٠
Ser
RO61643
16
Ultrasound Device Indications Statement Page of 20
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 | 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:
** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
Lacey (radion
no sinn Sinn Mit of Reproductive, Abdomina . minomasi De SE . THEIR
17
Ultrasound Device Indications Statement Page 13 of 20
1061 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA57R-0375WU
ce Name : Diagnostic Ultrasound System DDC-1200110, 71497R 09179 Rev
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)
) January (neider
vision Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643
18
Ultrasound Device Indications Statement Page _14_of_20
12061643 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 | | N | N | N | | N | N | N | N | N | |
| Abdominal | | 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)
Description Use
Aarici Broglioni
vision Sion-Off on of Reproductive, Abdomi adinlogical Device 1 : 12 : 32 : 1963 :
19
Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_15 of 20
KB6164 510(k) Number (if known) : _ 910(K) Namoor (111210"). 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:
| 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 | |||
| 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)
Prescription Use
Jancy Cileari
Division Sign-Off
- Reproductive, Abdomina (admingical Devices inde Nomber ..
20
Ultrasound Device Indications Statement Page _16 _of_20
510(k) Number (if known) : _ K 0 b 1 6 4 3 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 | | N | N | N | | N | N | N | N | N | |
| 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Harry Crighton
Division Sign Off
Division of Reproductive, Abdominal,
and Radiological Devices
Safety Number
2061643
21
Ultrasound Device Indications Statement Page 17 of 20
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:
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 | |
| 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) | | | | | | | | | | | |
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S. Lacey C. Hopton
Liver, Other
Non-Invasive, Abdominal,
22
Ultrasound Device Indications Statement Page _ 18 of 20
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:
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 | | | | | | | | | | | | |
| Abdominal | | | | N | | N | N | | | N | | |
| Intra-operative
(Specify) | | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | | |
| Small Organ
(Specify) * | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | N | 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) | | | | | | | | | | | | |
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Stacey L. McAlister
Permission Sign-Off
on on Reproductive, abdomina Gological Desices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
Ultrasound Device Indications Statement Page 19 of 20
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 | | | | N | N | N | N | | | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| 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 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)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD Harmonic Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Henry C. Newton
LL061643
24
Ultrasound Device Indications Statement Page 20 of 20
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:
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 | | | | | | | | | | | |
| Abdominal | | | | N | | N | N | | | N | |
| Intra-operative | | | | | | | | | | | |
| (Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| (Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| 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) | | | | | | | | | | | |
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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Division Sign-Off)
Division of Reproductive. Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________