(15 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology and display modes.
No
The device is strictly for diagnostic imaging and does not provide therapy. Its intended use is described as "diagnostic ultrasound imaging analysis" and it produces "ultrasound waves into body tissue and to present the returned echo information on the monitor."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging analysis." The "Device Description" also refers to it as a "digital ultrasonic diagnostic system."
No
The device description explicitly states it is a "portable digital ultrasonic diagnostic system" that "employs an array of probes" and produces ultrasound waves, indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The DUS 60 Digital Ultrasonic Diagnostic Imaging System uses ultrasound waves to create images of internal body structures. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound imaging analysis" of various anatomical sites within the body.
Therefore, based on the provided information, the DUS 60 is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms. obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial). Urology (including prostate). Transrecta and Transvagina.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
DUS 60 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.
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: B-Mode, M-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrecta and Transvagina.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or similarly qualified health care professional / gynecology rooms. obstetrics rooms, examination rooms, intensive care units, and emergency rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test:
The following safety standards are conducted on the subject device:
- (1) IEC 60601-1 and IEC 60601-2-37 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
. ▼ - ..
ﺘﺮ
Section 5 - 510(k) Summary
APR 2 6 2011
9
Prepared in accordance with the requirements of 21 CFR Part 807.92
. . . . .
| 1. Submitter: | Edan Instruments, Inc.
3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,
Nanshan Shenzhen, 518067 P.R. China
Tel.: (0755) 26858736
Fax: (0755) 26882223 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Randy Jiang |
| Prepare date: | Feb 06, 2011 |
| 2. Device name
and classification: | Device Name:
Digital Ultrasonic Diagnostic Imaging System, Model DUS 60
Classification Name:
892.1560 System, Imaging, Pulsed echo, Ultrasonic
Product code: IYO
892.1570 Transducer, Ultrasonic, Diagnostic
Product code: ITX
Regulatory Class: Class II |
| 3. Predicate
Device: | DUS 6 Digital Ultrasonic Diagnostic Imaging System / K091680 / Edan Instruments, Inc.
DC-3 Diagnostic Ultrasound System / K081320 / Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
| 4. Device
Description: | DUS 60 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.
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: B-Mode, M-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. |
1
5. Intended Use:
The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms. obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial). Urology (including prostate). Transrecta and Transvagina.
6. 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 and IEC 60601-2-37 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) 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
7. Comparison to the Predicate Device
Comparison to the predicate devices, the subject device has the similar technology characteristics and has the same intended use, same design principle, same electrical classification and same accuracy. The mainly difference between the subject device and predicate devices primarily includes physical specifications, display monitor and display mode. All above differences do not affect the usage, safety and effectiveness, and no new question is raised regarding the safety and effectiveness.
8. Substantially Equivalent Determination
The related tests (including safety, EMC, performance and biocompatibility) of the entire device were conducted on the DUS 60 Digital Ultrasonic Diagnostic Imaging System. This premarket notification submission demonstrates that DUS 60 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 2 6 2011
Edan Instruments % Mr. Marc M. Mouser Engineering Leader & FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K110999
Trade/Device Name: Digital Ultrasonic Imaging Systems, Model DUS 60 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: March 8, 2011 Received: April 11, 2011
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Digital Ultrasonic Imaging Systems, Model DUS 60, as described in your premarket notification:
Transducer Model Number
| C363UA | L742UA |
|---|---|
| C362UA | L763UA |
| C343UA | E743UA |
| C321UA | E613UA |
| L743UA | C613UA |
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely Yours,
Mary S Pastil
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Digital Ultrasonic Diagnostic Imaging System 510K Submission
Section 6 - Indications for Use
510(k) Number (if known):
Device Name: Digital Ultrasonic Diagnostic Imaging System, Model DUS 60
The Digital Ultrasonic Diagnostic Imaging System DUS 60 is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrecta and Transvagina.
| Prescription Use | X |
|---|---|
| (21 CFR Part 801 Subpart D) | |
| Or Over the Counter Use | |
| (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Mary S Postl
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K110999
Page 1 of 12
5
DUS 60 Digital Ultrasonic Diagnostic Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | N | N | N | N | Note 1 | ||
| Adult Cephalic | |||||||
| Transrectal | N | N | N | N | Note 1 | ||
| Transvaginal | N | N | N | N | Note 1 | ||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | N | N | N | N | Note 1 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Cardiac | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Peripheral vascular | N | N | N | N | Note 1 | ||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Mary S. Castle
(Division Sign Off)
Orvision Sinr Division of Radiological De Office of In Evaluation and Safety 510K
Page 2 of 12 6-2
6
DUS 60 with C363UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | |||||||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
Mary Slatu
(Division Sign-Off)
Division of Radiological Review
Page 3 of 12
Division of Radiological Device Office of In Diagnostic Device Evaluation and Safety 510K
6-3
7
DUS 60 with C362UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | ||
| Ophthalmic | ||||||||
| Fetal / Obstetrics | N | N | N | N | Note 1 | |||
| Abdominal | N | N | N | N | Note 1 | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neurological) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | |||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Cardiac | ||||||||
| Intravascular | ||||||||
| Peripheral vascular | ||||||||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OVD)
Prescription Use (Per 21 CFR 801.109)
Mary S. Poty
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety . E10K
Page 4 of 12
8
DUS 60 with C343UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | |||||||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OVD)
810K
Prescription Use (Per 21 CFR 801.109)
Mary Stotel
(Division Sign Off)
Office of in
Page 5 of 12
9
DUS 60 with C321UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||
| (Specify) | Other* | ||||||
| (Specify) | |||||||
| Ophthalmic | |||||||
| Fetal / Obstetrics | |||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | N | N | N | N | Note 1 | ||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Cardiac | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Peripheral vascular | |||||||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
510K
Prescription Use (Per 21 CFR 801.109)
Mary S. Postl
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 6 of 12
6-6
10
DUS 60 with L743UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | |||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | N | N | N | N | Note 1 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Cardiac | |||||||
| Peripheral vascular | N | N | N | N | Note 1 | ||
| Other (Urology) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
Mary S Patel
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110999
Page 7 of 12 6-7
11
DUS 60 with L742UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | Combined
(Specify) | Other*
(Specify) |
|---------------------------------|-------------------|---|-----|-----|------------------|---|-----------------------|---------------------|
| | B | M | PWD | CWD | Color
Doppler | | | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | |
| Abdominal | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (Specify) | N | N | N | | | N | Note 1 | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | N | | | N | Note 1 | |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 | |
| Intravascular | | | | | | | | |
| Cardiac | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | N | N | N | | | N | Note 1 | |
| Other (Urology) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
Mary Shishl
(Division Sign-Off)
on Sion-Division of Rediological Devices Office of In Vitro D tic Device Evaluation and Sately 510K
Page 8 of 12 6-8
12
Digital Ultrasonic Diagnostic Imaging System 510K Submission
Diagnostic Ultrasound Indications for Use Form
DUS 60 with L763UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | |||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | N | N | N | N | Note 1 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | N | N | N | N | Note 1 | ||
| Other (Urology) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
510K
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
Office of In ce Evaluation and Safety Page 9 of 12
6-9
13
DUS 60 with E743UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
1
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| ਤਿ | M | PWD | CWD | Color | Combined | Other* | ||
| Doppler | (Specify) | (Specify) | ||||||
| Ophthalmic | ||||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neurological) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Transrectal | N | N | N | N | Note l | |||
| Transvaginal | ||||||||
| Transurethral | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Cardiac | ||||||||
| Intravascular | ||||||||
| Peripheral vascular | ||||||||
| Other (Urology) | N | N | N | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
610K
Prescription Use (Per 21 CFR 801.109)
Mary Stotler
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 10 of 12
6-10
14
DUS 60 with E613UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | |||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | N | N | N | N | Note 1 | ||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | |||||||
| Other (Urology) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
Mary Pashl
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K110999
Page 11 of 12
6-11
15
Digital Ultrasonic Diagnostic Imaging System 510K Submission
Diagnostic Ultrasound Indications for Use Form
DUS 60 with C613UA Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | |
| Ophthalmic | |||||||
| Fetal / Obstetrics | |||||||
| Abdominal | |||||||
| Intra-operative (Specify) | |||||||
| Intra-operative (Neurological) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | ||
| Small Organ (Specify) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Transrectal | |||||||
| Transvaginal | |||||||
| Transurethral | |||||||
| Musculo-skeletal (Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Cardiac | N | N | N | N | Note 1 | ||
| Intravascular | |||||||
| Peripheral vascular | |||||||
| Other (Urology) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M;
Note 1: 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 Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
Mary Statel
(Division Sign-Off)
Division of Office of In ation and Safety BIOK
Page 12 of 12
6-12