DUS-7000 Digital Color Doppler Ultrasound System
Device Facts
| Record ID | K172055 |
|---|---|
| Device Name | DUS-7000 Digital Color Doppler Ultrasound System |
| Applicant | Advanced Instrumentations, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 31, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Device Story
DUS-7000 is a mobile, software-controlled, color diagnostic ultrasound system. It transmits ultrasonic energy into the patient body and processes received echoes to generate real-time images of anatomic structures and fluid flow. The system includes a mobile console, keyboard control panel, power supply, color LCD monitor, and various interchangeable probes (linear, convex, phased arrays). It operates in B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, Power Doppler, Elastography, and 3D/4D modes. Used in clinical settings by physicians, the device provides high-resolution diagnostic images to assist in clinical evaluation and decision-making across multiple medical specialties. It benefits patients by enabling non-invasive visualization of internal anatomy and hemodynamics.
Clinical Evidence
No clinical data. Bench testing only. Performance verified via laboratory testing for electrical, mechanical, thermal, and electromagnetic safety, biocompatibility, and acoustic output per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, UD2, and UD3. Phantom testing verified strain Elastography accuracy and repeatability.
Technological Characteristics
Mobile console with color LCD monitor; frequency range 2.0-15.0 MHz; supports linear, convex, and phased array probes. Imaging modes: B-Mode (THI), M-Mode, TDI, Color-Flow, PW/CW Doppler, Power Doppler, Elastography, 3D/4D. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5/10, NEMA UD2/UD3.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound imaging and fluid flow analysis of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, musculo-skeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urological applications.
Regulatory Classification
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.
Predicate Devices
- Sonoscape S22 (K142815)
Related Devices
- K160283 — S45 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Apr 4, 2016
- K152396 — S12 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 3, 2015
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K102642 — SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO · Sonoscape Company Limited · Mar 4, 2011
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Advanced Instrumentations. Inc. % Jorge Millan, Ph.D. Regulatory Affairs Manager 6800 NW 77th CT MIAMI, FL 33166
Re: K172055
Trade/Device Name: DUS-7000 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 20, 2017 Received: July 6, 2017
Dear Dr. Millan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K172055
Device Name
DUS-7000 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Type of Use (Select one or both, as applicable)
1 Prescription Use (Part 21 CFR 801 Subpart D) — Over-The-Counter Use (21 CFR 801 Subpart C)
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# Diagnostic Ultrasound Indications for Use Form DUS-7000 Ultrasonic Diagnostic Imaging System
| Clinical Application | | Mode of Operation | | | | | | | | |
|-------------------------|---------------------------------|-------------------|---|----|----|-------|-------|------------------------|---------------------|--|
| General (Track 1 only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined (Specify) [1] | Other (Specify) [2] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging and Other | Fetal | P | P | P | | P | P | Note 1 | Note 2,4,5 | |
| | Abdominal | P | P | P | | P | P | Note 1 | Note 2,4,5 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Small Organ (Specify) * | P | P | P | | P | P | Note 1 | Note 2,4,6 | |
| | Neonatal Cephalic | P | P | P | | P | P | Note 1 | Note 2,3,4 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | Note 2,3,4 | |
| | Trans-rectal | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Note 2,4,5 | |
| | Other (Urology) | P | P | P | | P | P | Note 1 | Notes 2, 4 | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Note 2,3,4 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Note 2,3.4 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | Note 1 | Note 2,3.4 | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | Note 2,4 | |
| | Other (Urology) | | | | | | | | | |
#### Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form DUS-7000 with 2P1 Phase Array Transducer
| | Clinical Application | | | | | | | | Mode of Operation | |
|----------------------------|--------------------------------|---|---|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | Note 1 | Notes 2, 4 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other(Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form DUS-7000 with 5P1 Phase Array Transducer
| | Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|--|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging | Fetal | | | | | | | | | | |
| and Other | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 | | |
| | Small Organ (Specify) * | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| | Other(Urology) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (Urology) | | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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## Diagnostic Ultrasound Indications for Use Form DUS-7000 with C613 Micro-curved Array Transducer
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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# Diagnostic Ultrasound Indications for Use Form DUS-7000 with 6V1 Micro-Curved Array Transducer
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|---------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|--|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| Fetal Imaging | Fetal | | | | | | | | | | | |
| and Other | Abdominal | | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| | Pediatric | | | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | P | Note 1 | Notes 2,4 | | | |
| | Trans-vaginal | P | P | P | P | P | P | Note 1 | Notes 2,4 | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | | |
| | Intravascular | | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | | |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Notes 2,4 | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | | |
| Vessel | Other (Urology) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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# Diagnostic Ultrasound Indications for Use Form DUS-7000 with 6V3 Micro-Curved Array Transducer
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | |
|----------------------------|---------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,4 | | |
| | Trans-rectal | P | P | P | P | P | P | Note 1 | Notes 2,4 | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | | |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Notes 2,4 | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Urology) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents Note 3: TDI
Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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## Diagnostic Ultrasound Indications for Use Form DUS-7000 with EC9-5 Micro-Curved Array Transducer
| | Mode of Operation | | | | | | | | | |
|---------------------------|--------------------------------|---|---|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging | Fetal | | | | | | | | | |
| and Other | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form DUS-7000 with BCC9-5 Micro-Curved Array Transducer
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-7000 with BCL10-5 Biplane (Micro-curved + Linear Array) Transducer
# Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|-------------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][ | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | P | Note 1 | Notes 2,4 | |
| | Trans-vaginal | P | P | P | P | P | P | Note 1 | Notes 2,4 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form DUS-7000 with C344 Curved Array Transducer
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | P | P | P | P | P | P | Note 1 | Note 2,4 |
| | Abdominal | P | P | P | P | P | P | Note 1 | Note 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | P | P | P | Note 1 | Note 2,4 |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Note 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Urology) | | | | | | | | |
## Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form DUS-7000 with C353 Curved Array Transducer
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|-------------------|---|----|----|-------|-------|---------------------------|---------------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | P | P | P | P | P | P | Note 1 | Notes 2,4 |
| | Abdominal | P | P | P | P | P | P | Note 1 | Notes 2,4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | P | P | P | Note 1 | Notes 2,4 |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Notes 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Urology) | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-7000 with C542 Curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonics, The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ breast, thyroid, testes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form DUS-7000 with C354 Curved Array Transducer
| Clinical Application | | | Mode of Operation | | | | | | | |
|----------------------------|--------------------------------|---|-------------------|----|----|-------|-------|---------------------------|---------------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Power | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal | P | P | P | P | P | P | Note 1 | Note 2,4 | |
| | Abdominal | P | P | P | P | P | P | Note 1 | Note 2,4 | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | P | P | P | Note 1 | Note 2,4 | |
| | Other (Urology) | P | P | P | P | P | P | Note 1 | Note 2,4 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | |…
