(34 days)
K 122583, K113381, K 101757
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and analysis packages.
No.
The device is explicitly stated to be a "diagnostic ultrasound system" intended for "diagnostic ultrasound imaging and fluid analysis," and its function is to "acquire ultrasound data and to display the data" and "measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis." It does not provide any form of treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging and fluid analysis of the human body." Also, the "Device Description" mentions that it "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "general purpose, hand-held, software controlled, diagnostic ultrasound system," indicating it includes hardware components (the hand-held system) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging system used to visualize internal structures and analyze fluids within the body, not to perform tests on samples taken from the body.
- Device Description: The description focuses on acquiring and displaying ultrasound data in various modes (B mode, M mode, Color Doppler, etc.) and providing measurement and analysis packages for diagnosis. This is consistent with an ultrasound imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the UGEO PT60A Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organs, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PWSpectral Doppler mode, Harmonic imagingor as a combination of these modes. The UGEO PT60A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Small Organs, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel. Notes also include: Obstetrics, infertility monitoring of follicle development, for example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, Abdominal organs, and Gynecology.
Indicated Patient Age Range
Adult, Pediatric, Neonatal.
Intended User / Care Setting
Competent health care professionals. Intended for Prescription Use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable. The subject of this submission, UGEO PT60A, did not require clinical studies to support substantial equivalence.
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.
K 122583, K113381, K 101757
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
510(k) Premarket Notification
UGEO PT60A Diagnostic Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807. Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
SAMSUNGMEDISON CO., LTD. 42. Teheran-ro 108-gil, Gangnam-gu. Seoul, Korea
Contact Person: Kyeong-Mi. Park Regulatory Affairs Manager
Telephone: 82.2.2194.1373 Facsimile: 82.2.554.7567
Data Prepared: May 24, 2013
AUG 20 2013
.
2. Name of the device:
| Common/Usual Name: | ||
|---|---|---|
| Diagnostic Ultrasound System and Accessories | ||
| Proprietary Name: | ||
| UGEO PT60A Diagnostic Ultrasound System | ||
| Classification Names: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
3. Identification of the predicate or legally marketed device:
- UGEO H60 Diagnostic Ultrasound System(K 122583) -
- MySono U6 Diagnostic Ultrasound System(K113381) -
- SonoSite Maxx Series: M turbo (K 101757) .
1
5 10(k) Premarket Notification
4. Device Description:
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PWSpectral Doppler mode, Harmonic imagingor as a combination of these modes. The UGEO PT60A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
5. Intended Uses:
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analy sis of the human body.
The clinical applications include:Fetal, Abdominal, Small Organs, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
6. Technological Characteristics:
The UGEO PT60Ais substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO H60 Diagnostic Ultrasound System (K122583) and MySono U6 Diagnostic Ultrasound System (K113381).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the Advanced Needle Visualization of SonoSite Maxx Series; M Turbo (K101757) in regards to the device with Needle Mate.
All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow. and calculations.
These are described in detail in the technological characteristics comparison table as below.
510(k) Summary / Statement Certification
ATTACHEMENTI
2
510(t) Pemarket Norification
| The subject device | The predicate devices | |||
|---|---|---|---|---|
| Feature / Characteristics | UGEO PT60A | UGEO H60 | ||
| (K122583) | MySono U6 | |||
| (K113381) | Maxx Series | |||
| (K101757) | ||||
| Indication for Use | ||||
| - Fetal | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | |
| - Adult Cephalic | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | |
| - Trans-vaginal | √ | √ | √ | |
| - Musculo-skeletal (Conventional) | √ | √ | √ | √ |
| - Musculo-skeletal (Superficial) | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ |
| Scanhead Types | ||||
| - Linear Array | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | |
| - Endocavity | √ | √ | √ | |
| - Phased Array | √ | √ | √ | √ |
| - Static Probes | √ | |||
| Scanhead Frequency | ||||
| 1.0 - 20.0 MHz | √ | √ | √ | |
| Modes of Operation | ||||
| - B-mode | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ | √ |
| - Continuous wave (CW) Doppler | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ |
| - Power Amplitude Doppler | √ | √ | √ | √ |
| - Tissue Harmonic Imaging | √ | √ | √ | √ |
| - 3D/4D imaging mode | √ | √ | √ | √ |
| - Combined modes | √ | √ | √ | √ |
| Safety & EMC Compliance | ||||
| - IEC60601-1 | √ | √ | √ | √ |
| - UL 60601-1 | ||||
| - CSA C22.2 No.601.1 | ||||
| - IEC 60601-2-37 | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ |
| Acoustic Output Display Standard | √ | √ | √ | √ |
| Track 3 | ||||
| Patient Contact Materials | ||||
| Tested to ISO 10993-1 | √ | √ | √ | √ |
| Functionality | ||||
| - Quick Scan (Q Scan) | √ | √ | √ | √ |
| - Spatial Compound Imaging | √ | √ | √ | |
| - SMDR (Dynamic MR Plus) | √ | √ | √ |
:
3
510(k) Premarket Notification
UGEO PT60A Diagnostic Ultrasound System
| Feature / Characteristics | The subject device
UGEO PT60A | The predicate devices | |
|----------------------------------|----------------------------------|------------------------|--------------------------|
| | UGEO H60
(K122583) | MySono U6
(K113381) | Maxx Series
(K101757) |
| - Auto IMT | ✓ | | ✓ |
| - Needle Mate | ✓ | | ✓1) |
| 1) Advanced Needle Visualization | | | |
- Advanced Needle
- A brief discussion of the bench and non-clinical tests conducted on the subject device The device has been evaluated for acoustic output. biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.
The UGEO PT60A and its application comply with voluntary standards as below:
-
UL 60601-1. Safety requirements for Medical Equipment
-
CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
-
IEC60601-2-37, Diagnostic Ultrasound Safety Standards
-
EN/IEC60601-1,Safety requirements for Medical Equipment
-
EN/IEC60601-1-2,EMC requirements for Medical Equipment
-
EN/IEC60601-1-2,EMC requirements for Medical Equipment
NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment -
NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices
-
on Diagnostic Ultrasound Equipment
-
ISO10993-1. Biocompatibility
-
ISO10993-1. Biocompatibility
-
ISO14971, Application of risk management to medical devices
Summary of Clinical Tests:
Not applicable. The subject of this submission, UGEO PT60A, did not require clinical studies to support substantial equivalence.
8. Conclusion
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design. development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO.. LTD. considers the UGEO PT60Ato be as safe, as effective, and performanceis substantially equivalent to thepredicate devices.
END of 510(K) Summary
510(k) Summary / Statement Certification
ATTACHEMENT!
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
SAMSUNG MEDISON CO., LTD C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET NW BUFFALO MN 55313
Re: K132228
Trade/Device Name: UGEO PT60A 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: August 12, 2013 Received: August 13, 2013
Dear Mr. Job:
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 UGEO PT60A Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C2-8 | LN5-12 | PN2-4 |
|---|---|---|
| C2-5. | LS6-15 |
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.
5
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.fda.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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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.fdagov/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
6
SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known): _K132228
Device Name: UGEO PT60A Diagnostic Ultrasound System
Indications for Use:
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Small Organ, Adult Cephalic, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications for Use
Section 1.3. page 1 of 7
7
510(k) No.: Device Name: UGEO PT60A Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (* includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 7 | |
| Abdominal (See Note 8) | N | N | N | N | N | Note 1 | Notes 2, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & | ||||||||
| Other | Pediatric | |||||||
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 9 |
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
8
510(k) No.: Device Name: C2-5 for use with UGEO PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Abdominal (See Note 8) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA KI13381: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1 : B+M. B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
9
510(k) No.: Device Name: C2-8 for use with UGEO PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Abdominal | P | P | P | P | Note 1 | Notes 2, 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K113381: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
10
510(k) No.: Device Name: LN5-12 for use with UGEO PT60A
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Notes 2,5,6,9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Notes 2,5,6,9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Notes 2.5.6.9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 2,5,6,9 | |
| Other (spec.) |
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstettics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
11
510(k) No.:
·Device Name: LS6-15 for use with UGEO PT60A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 9 | |
| Other (spec.) |
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
12
510(k) No.: Device Name: PN2-4 for use with UGEO PT60A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (* includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | N | N | N | N | Note 1 | Note 7 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | Note 1 | Note 7 | ||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | Note 1 | Note 7 | ||
| Cardiac | Cardiac Pediatric | N | N | N | N | Note 1 | Note 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW
Note 2: Includes imaging for guidance of biopsy
Note 3: Obstetrics and Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: Includes Gynecology
Note 9: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
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Section 1.3, page 7 of 7
Indications for Use
510(k): K132228