DUS-6000 Digital Ultrasonic Diagnostic Imaging System
Device Facts
| Record ID | K172931 |
|---|---|
| Device Name | DUS-6000 Digital Ultrasonic Diagnostic Imaging System |
| Applicant | Advanced Instrumentations, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Dec 1, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.
Device Story
Portable diagnostic ultrasound system; inputs ultrasound waves into body tissue via various probes (convex, linear, micro-convex, endocavity); transforms returned echoes into images using digital beamforming, Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming, Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging; displays images on 12.1-inch LCD in B, 2B, 4B, M, B+M, or PW modes; used in hospitals/clinics by physicians/qualified professionals; output aids diagnostic imaging analysis; benefits patient through non-invasive visualization of internal structures and fluid flow.
Clinical Evidence
No clinical data; bench testing only. Safety and performance verified via IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic safety), ISO 10993-1/5/10 (biocompatibility), and acoustic output testing per FDA guidance.
Technological Characteristics
Portable ultrasound system with 12.1-inch LCD. Features: Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming, Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging. Probes: convex, linear, micro-convex, endocavity. Connectivity: automatic probe detection. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993. Biocompatible needle-guide brackets.
Indications for Use
Indicated for ultrasound evaluation in hospitals and clinics for abdominal, obstetric, gynecological, pediatric, small parts (including thyroid), urological, peripheral vascular, musculoskeletal (conventional and superficial), and cardiac applications. Used by or on the order of a physician or qualified healthcare professional.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- DUS 60 ultrasound system (K131830)
Related Devices
- K142511 — U50 Diagnostic Ultrasound System · Edan Instruments, Inc. · Feb 20, 2015
- K212900 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 5, 2021
- K123249 — DIAGNOSTIC ULTRASOUND SYSTEM · Edan Instruments, Inc. · Feb 8, 2013
- K180408 — U60 Diagnostic Ultrasound System · Edan Instruments, Inc. · Apr 13, 2018
- K160343 — SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner · Beijing East Whale Imaging Technology Co., Ltd. · Apr 7, 2016
Submission Summary (Full Text)
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December 1, 2017
Advanced Instrumentations, Inc. % Jorge Millan, Ph.D. Regulatory Affairs Manager 6800 NW 77th Ct. MIAMI FL 33166
Re: K172931
Trade/Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 3, 2017 Received: October 6, 2017
Dear Dr. Millan:
We have reviewed vour 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 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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(1-800-638-2041 or 301-796-7100).
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Sincerely,
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)
K172931
Device Name
DUS-6000 Digital Ultrasonic Diaqnostic Imaqing System
Indications for Use (Describe)
The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.
| Type of Use (Select one or both, as applicable) | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|
| ಸ<br>Prescription Use (Part 21 CFR 801 Subpart D)<br>- Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | | | | | |
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EF
PSC Publishing Services (301) 443-674
FORM FDA 3881 (8/14)
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#### Diagnostic Ultrasound Indications for Use Form DUS-6000 Digital Ultrasonic Diagnostic Imaging System
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | | | | | | |
|----------------------------|--------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | | P | Note 1,2 |
| | Small Organ (Specify) * | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | | P | Note 1,2 |
| | Trans-vaginal | P | P | P | | | P | Note 1,2 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | |
| | Other (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | P | P | P | | | P | Note 1,2 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | | P | Note 1,2 |
| vascular | Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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#### Diagnostic Ultrasound Indications for Use Form DUS-6000 with C361-2 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | 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 (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{5}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form DUS-6000 with C363-2 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | 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 (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{6}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-6000 with C341-2 Transducer
| | Clinical Application | | | | | | | |
|----------------------------|--------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | 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 (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{7}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-6000 with L741-2 Transducer
| Clinical Application | | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------|--------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | |
| | Other (Specify)** | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | | P | Note 1,2 |
| | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-6000 with L743-2 Transducer
| | Clinical Application | | | | | | | |
|---------------------------|--------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging | Fetal/Obstetrics | | | | | | | |
| and Other | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | |
| | Other (Specify)** | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | | P | Note 1,2 |
| Vascular | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-6000 with L761-2 Transducer
| | Clinical Application | | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------|--------------------------------|--|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | | |
| | Other (Specify)** | | | | | | | | |
| Cardiac | Cardiac | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | P | P | P | | | P | Note 1,2 |
| | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form DUS-6000 with C611-2 Transducer
| Clinical Application | | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1<br>only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | | P | Note 1,2 |
| | 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 (Specify)** | | | | | | | |
| Cardiac | Cardiac | P | P | P | | | P | Note 1,2 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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## Diagnostic Ultrasound Indications for Use Form DUS-6000 with E741-2 Transducer
| | Clinical Application | | | | | | | | |
|---------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) | |
| | Ophthalmic | | | | | | | | |
| Fetal Imaging | Fetal/Obstetrics | | | | | | | | |
| and Other | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | | P | Note 1,2 | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify)** | | | | | | | | |
| Cardiac | Cardiac | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | | |
| vascular | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
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## Diagnostic Ultrasound Indications for Use Form DUS-6000 with E611-2 Transducer
| | Clinical Application | | | | | | | | |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|--|
| General (Track 1<br>only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>and Other | Fetal/Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | | P | Note 1,2 | |
| | Trans-vaginal | P | P | P | | | P | Note 1,2 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify)** | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | | |
| | 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, B+PW
*Small Organ includes thyroid
**Other use includes Urology
Note 1: Biopsy guidance
Note 2: Harmonic Imaging, This feature does not use contrast agents
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#### 510K SUMMARY
DUS-6000 Digital Ultrasonic Diagnostic Imaging System
- SUBMITTER ADVANCED INSTRUMENTATIONS, INC 6800 NW 77th Ct, Miami, FL 33166 Phone: (305) 477-6331
- US AGENT JORGE MILLAN, PHD REGULATORY AFFAIRS MANAGER Email: sigmabiomedical@gmail.com Web: https://www.sigmabiomedical.com
#### DEVICE NAME AND CLASSIFICATION
| TRADE NAME: | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | |
|----------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | 892.1560<br>Product Code: IYO<br>892.1570<br>Product Code: ITX | System, Imaging, Pulsed echo, Ultrasonic<br>Transducer, Ultrasonic, Diagnostic |
| REGULATORY CLASS: | Class II | |
| PANEL IDENTIFICATION | Radiology | |
#### DEVICE DESCRIPTION
The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.
It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.
The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.
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Predicate Devices: The proposed system model is substantially equivalent to diagnostic ultrasound systems cleared for marketing in the US. The DUS-6000 Ultrasound system is equivalent to the DUS 60 ultrasound system (K131830), manufactured by EDAN Instruments Inc.
Indications for Use: The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.
#### EFFECTIVENESS AND SAFETY CONSIDERATIONS
#### Clinical Test:
Clinical testing is not required.
#### Non-clinical Test:
The following safety standards are conducted on the subject device:
(1) IEC 60601 -1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
(4) ISO 10993-1. ISO 10993-5 and ISO 10993-10 Biological Evaluation of medical devices
## Comparison to the predicate device
The subject device has similar technology characteristics and has the same intended use, same design principle, same electrical classification and same accuracy. There are no differences between the devices that affect the usage, safety and effectiveness. The subject device has the same needle-guide bracket material, property, and sterilization methods as those of the predicate device DUS 60, therefore, the needle-guide bracket will not cause any safety and effectiveness issues.
## Substantially Equivalent Determination
This premarket notification submission demonstrates that the DUS-6000 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices.
