DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K132059 |
|---|---|
| Device Name | DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Advanced Instrumentations, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 25, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Device Story
DUS-5000 is a diagnostic ultrasound system for hospital/clinic use. It acquires and displays ultrasound images in B, M, PW, Color, and PDI/DPDI modes. Input is provided via various probes (linear, convex, micro-convex; 2.5-11 MHz). The system utilizes Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging to process signals. Output is displayed on a 12.1-inch LCD. Physicians use these images for diagnostic evaluation of various anatomical regions. The device aids clinical decision-making by providing clear, stable images for assessment of anatomy and fluid flow.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing per FDA guidelines, and biocompatibility (ISO 10993-1, -5, -10).
Technological Characteristics
Diagnostic ultrasound system with 12.1-inch LCD. Probes: linear, convex, micro-convex (2.5-11 MHz). Imaging modes: B, M, PW, Color, PDI/DPDI. Technologies: Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), Spatial Compounding Imaging. Compliance: IEC 60601-1, IEC 60601-1-2, ISO 10993 series.
Indications for Use
Indicated for ultrasound evaluation in adults, pregnant women, and pediatric patients. Clinical applications include abdominal, obstetrics, gynecology, pediatric, small parts (thyroid, testes, breast), urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal, and cardiac. Used in hospitals and clinics by physicians or qualified healthcare professionals.
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
- Model U50 Diagnostic Ultrasound System (K123249)
Submission Summary (Full Text)
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DUS-5000 Diagnostic Ultrasound System
page 1 of 3
# 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
#### Submitter
Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: 305-477-6331 305-477-5351 Fax:
Registration # 1066270
#### Official correspondent :
Jorge Millan, PhD Email: imillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260
Date Prepared:
OCT 25 2013
October 24, 2013
#### Device name and classification:
- DUS-5000 Diagnostic Ultrasound System Device Name: .
- Classification Name: 892.1550 System, Imaging, Pulsed Doppler Ultrasonic 0 Product code: IYN 892.1560 Ultrasonic, Pulsed echo, Imaging Product code: IYO 892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITX
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#### Regulatory Class: Class II .
#### Predicate Device:
Model U50 Diagnostic Ultrasound System, K123249 Manufacturer: EDAN Instruments
#### Device Description:
The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images.
Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.
#### Intended Use:
The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician *or similarly qualified health care professional.
#### Effectiveness and Safety Contraindications:
#### Clinical Test
Clinical testing is not required
#### Non-clinical test:
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K132059
Page 3 of 3
The following safety standards are conducted on the subject device:
- 1. IEC 60601 -1 Electrical Safety
- 2. IEC 60601-1-2 Electromagnetic Compatibility
- 3. Acoustic output testing as per the quideline "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
#### Comparison to the predicate device:
The subject device has identical technology characteristics, same intended use, same product design, materials and manufacturing process, as well as same performance effectiveness, performance safety and the same needle-guide bracket material, property and sterilization methods as the predicate device.
#### Substantially Equivalent Determination:
This premarket notification submission demonstrates that DUS-5000 Diagnostic Ultrasound System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS emblem, which is a stylized representation of a human figure embracing the world. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. The emblem is black and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2013
Advanced Instrumentations, Inc. % Jorge Millan, Ph.D. Official Correspondent Hialeah Technology Center, Inc. 601 West 20 Street HIALEAH FL 33010
Re: K132059
Trade/Device Name: DUS-5000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 8, 2013 Received: October 10, 2013
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.
This determination of substantial equivalence applies to the following transducers intended for use with the DUS-5000 Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
| C352UB | E612UB | C422UB |
|---------|---------|--------|
| L1042UB | C612UB | L552UB |
| L742UB | C6152UB | |
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.
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#### Page 2-Dr. Millan
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.gov/MedicalDevices/Safets/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Advanced Instrumentations DUS-5000 Diagnostic Ultrasound System 510K Submission
### Indications for Use
510(k) Number (if known): K132059
Device Name: DUS-5000 Diagnostic Ultrasound System
Intended Use:
The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vasculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Or Over the Counter Use _ Prescription Use (21 CFR Part 801 Subpart D)
(21 CFR Part 801 Subpan C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
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ﺮ ﺩﺭ
### Diagnostic Ultrasound Indications for Use Form
### DUS-5000 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | | P | P | P |
| | Adult Cardiac | P | P | P | | P | P | P |
| Cardiac | Pediatric Cardiac | P | P | P | | P | P | P |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breas Nole
** Other use includes Urology, Kidney, Gynecology -
111:PDI: Power Doppler Imaging , DPDI; Directional Power Doppler Imaging
(2); Biopsy Gujdance
[3]; Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE: - CONTINUE ON ANOTHER PAGE IF NI:EDIED)
Concurrence of CDRH: Office of In Vitro Diugnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
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## Diagnostic Ultrasound Indications for Use Form
#### DUS-5000 with C352UB Transducer
Intended Use: Diagnostic ultrasound imaging or theid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | | P | P | P |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI, B+Color+PW, I}+PDI/DPDJ +PW * Small Organ includes Thyroid, Testes, Breast |Cleured applications under K123249 Note
** Qther use includes Urology, Kidney, Gynecology
[1]: PDI: Power Doppler Imaging , DPDI: Directional Power Doppler Imaging
[2]: Bionsy Guidance
[3]; Harmonic Imaging, This feature does not use contrast agent.
(PI.EASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NET.DED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
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### Diagnostic Ultrasound Indications for Use Form
| DUS-5000 with L1042UB |
|-----------------------|
| Transducer |
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|----------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify)1 | Other<br>(Specify)23 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | P | P | P | P |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | P | P | P | P |
| vascular | Other (Specify) | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, 13+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under_ K123249___________________________________________________________________________________________ Note
· Other use includes Urology, Kidney, Gynecology
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>111: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 121: Bionsv Guidance | |
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BIELOW THIS LINE - CONTINUE ()N ANOTHER PAGE IF NEIJID)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Pcr 21 CFR 801.109)
6-4
.
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#### DUS-5000 with L742UB Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|--------------------------|--------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify)[1] | Other<br>(Specify)[2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) * | P | P | P | P | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | P | P | P | P |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast (Cleared applications under K123249_ Nore
** Other use includes Urology, Kidney, Gynecology
111: PD1: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging 12): Biopsy Guidance
131: Harmonic Imaging, This feature does not use contrast agent
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Pcr 21 CFR 801,109)
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#### DUS-5000 with E612UB Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|------------|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | |
| Imaging | Adult Cephalic | | | | | | | |
| & Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-csoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+P()//DPD). B+Color+PW. B+PD)//DPDI +PW * Small Organ includes Thyroid, Testes, Breast |Cleared applications under_K123249_ Nolc
** Other use includes Urology, Kidney, Gynecology
ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ [ I ]: PDI: Power Doppler Imaging , DPD]; Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Jmaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II' NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
{11}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
#### DUS-5000 with C612UB Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) 111 | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | l.aparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | P | P | P | P | P | P | P |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cicared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI. B+Color+PW. B+PDJ/DPDI +PW * Small Organ includes Thyroid, Testes, Breast (Cleared applications under K123249____________________________________________________________________________________________ Nole
** Other use includes Unplogy, Kidney, Gynecology
11): PDI: Power Doppler Imaging ,DPI)); Directional Power Doppler Imaging , commen
121: Biopsy Guidance
[3]; Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NIJEIDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109) -
·
{12}------------------------------------------------
#### DUS-5000 with C6152UB Transducer
| | Clinical Application | Mode of Operation | | | | | | | |
|------------|---------------------------------|-------------------|---|-----|-----|-------|-----------------------|-------------------------|--|
| General | Specific | િ | M | PW | C.W | Color | Combined<br>(Specify) | Other<br>(Specify) ואנג | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obsteiries | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | |
| | Small Organ (Specify) * | | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | | |
| Imaging | Adult Cephalic | | | | | | | | |
| & Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urcthral | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skelctal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) ** | | | | | | | | |
| | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | P | P | ાંગ | | P | p | P | |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | | |
| vascular | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Dopply: Imaging Additional comments: Combined mode: B+M. B+PW, B+Color, B+PDI/DPDI、B+Color+PW. B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under K123248___ Note
** Other use includes Urology, Kidney, Gynccology
| [1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging |
|--------------------------------------------------------------------------|
| [2]: Biopsy Guidance |
131: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS 1.INE: - CONTINUE ON ANOTHER PAGE IF NEEDDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
{13}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### DUS-5000 with C422UB Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | P | P | P | P | P | P | P |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW, B+Color, B+PDI/DPDI. B+Color+PW. B+PDI/DPDI +PW * Small Organ includes Thyroid. Testes, Breast ICleared applications under_K123249_ Note -
** Other use includes Urology, Kidney, Gynecology,
[]]: PDI: Power Doppler Imaging .DPDI: Directional Power Doppler Imaging
[2]; Bjopsy Guidance _________________________________________________________________________________________________________________________________________________________ -
[3]: Harmonic Imaging, This feature does not use contrast agent,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (O!R)
Prescription Use (Per 21 CFR 801.109)
{14}------------------------------------------------
### DUS-5000 with L552UB Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|------------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][1][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Specify) * | | P | P | P | | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI. B+Color+PW. B+PDJ/DPD) +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under K123249 Note
** Other use includes Urology, Kidney, Gynecology
・ 111: PD1: Power Doppler Imaging JDPDI: Directional Power Doppler Imaging
12): Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE: - CONTINUI: ON ANOTHIER PAGE IF NEEDED)
Concurrence of CDRH; Office of in Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
{15}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
#### DUS-5000 with LS52UB Transducer
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|-----------------------|
| | | B | M | PW | CW | Color | Combined<br>(Specify)1 | Other<br>(Specify)2,3 |
| General | Specific | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Specify) * | P | P | P | P | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | P | P | P | P |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under_K123249_ NoIc
** Other use includes Urology, Kidney, Gynecology.
11): PDI: Power Doppler Imaging JDPDI: Directional Power Doppler Imaging
[2] Biopsy Guidance
131: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BIELOW THIS LINE: - CONTINUI: ON ANDTHIER PAGIE IF NI!!!!)]!!))
Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
