UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K122583 |
|---|---|
| Device Name | UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Samsung Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 5, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The UGEO G60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), and Peripheral vessel.
Device Story
UGEO G60 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in B-mode, M-mode, Color/Power Doppler (including S-Flow), PW Spectral Doppler, Harmonic imaging, and 3D/4D imaging. Operated by healthcare professionals in clinical settings, the system provides anatomical measurements and analysis packages to assist in diagnosis. It features real-time acoustic output display (mechanical and thermal indices). Clinicians use the displayed images and measurements to guide clinical decision-making, such as biopsy guidance or monitoring follicle development. The device benefits patients by providing non-invasive diagnostic imaging and fluid flow analysis.
Clinical Evidence
Bench testing only. The device underwent performance testing to verify compliance with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1. No clinical data was required for this 510(k) submission.
Technological Characteristics
Mobile diagnostic ultrasound system. Materials comply with ISO 10993-1. Sensing principle: ultrasonic pulsed echo and Doppler imaging. Energy source: electrical. Connectivity: standard ultrasound system interfaces. Software: system-controlled. Sterilization: transducers are compatible with standard clinical cleaning/disinfection protocols. Safety standards: UL 60601-1, IEC 60601-2-37, NEMA UD-2/UD-3.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ, neonatal cephalic, transrectal, trans-vaginal, musculoskeletal, and peripheral vessel applications in adult, pediatric, and neonatal patients.
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
- ACCUVIX A30 Diagnostic Ultrasound System (K112339)
- ACCUVIX V20 Diagnostic Ultrasound System (K092159)
Related Devices
- K133329 — UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Nov 27, 2013
- K143264 — H60 V2.00 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 9, 2014
- K130803 — UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Apr 12, 2013
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
- K142466 — UGEO PT60A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Oct 3, 2014
Submission Summary (Full Text)
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K122583
510(k) Premarket Notification
UGEO G60 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)
SEP 5 2012
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: June 15, 2012
### 2. Name of the device:
| Common/Usual Name: | | |
|----------------------------------------------|-----------|--------------|
| Diagnostic Ultrasound System and Accessories | | |
| Proprietary Name: | | |
| UGEO G60 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:
- ACCUVIX A30 Diagnostic Ultrasound System(K112339) .
- ACCUVIX V20 Diagnostic Ultrasound System(K092159) •
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### 510(k) Premarket Notification
### 4. Device Description:
The UGEO G60 is a general purpose, mobile, 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(including Directional Power Doppler mode; S-Flow), PWSpectral Doppler mode, Harmonic imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO G60 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 G60 has real time acoustic output display with two basic inclices, a mechanical index and a thermal index, which are both automatically displayed.
The UGEO G60has been designed to meet the following product safety standards:
- 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
- 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
- IEC 61157. Declaration of the acoustic output
- ISO10993-1, Biocompatibility
### 5. Intended Uses:
The UGEO G60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), and Peripheral vessel.
### 6. Technological Characteristics:
The UGEO G60is substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX A30 Diagnostic Ultrasound System (K112339) and ACCUVIX V20 Diagnostic Ultrasound System (K092159).
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.
### END of 510(K) Summary
510(k) Summary / Statement Certification
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K122583
Trade/Device Name: UGEO G60 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 23, 2012 Received: August 24, 2012
Dear Mr. Job:
This letter corrects our substantially equivalent letter of September 5, 2012.
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.
OCT 1 2 2012
This determination of substantial equivalence applies to the following transducers intended for use with the UGEO G60 Diagnostic Ultrasound System, as described in your premarket notification:
### Transducer Model Number
| rand<br>1<br>A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>4<br>raud a<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ATA<br>-<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| t<br>C<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Acres on and artists of the contribution of<br>€<br>. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----------- |
| 1<br>1<br>1<br>A AND AND . AND . AN | œ<br>1 | S<br>1 |
{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/ReportaProblem/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 Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours.
Munkal D'Ohm to
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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## SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: UGEO G60 Diagnostic Ultrasound System
Indications for Use:
The UGEO G60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superticial), 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)
Aratand D'Ohm
(Division Sign-Off)
Division of Radiological Devices
510k K122583
Indications for Use
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## 510(k) No.: Device Name: UGEO G60 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or Nuid Now analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & II) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Neonatal Cephalic | N | N | N | | N | Note 1 | Note 2, 7, 8 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | N | N | N | | N | Note 1 | Note 2, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 10 |
| | Musculo-skel. (Supertic.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 10 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 10 |
| | 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+DPD, B+C · PW, B+PD+PW, B+C)MD; PW, Dwal Quad B+C , B+PD, B+DPD
Note 2: Includes maging for guidance of bropsy
Note 3: Includes infortility montoring of follicle development
Nate 4: Color M-modc
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel .
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|-------------------------------------------------------------------|
| Paturintion Live (Per 21 CFR 801 109) |
Prescription Use (Per 2
Indications fyy
(Division Sign-Off)
Division of Radiological Devices
510k 5127583
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### 510(k) No.: Device Name: CSI-4 for use with UGEO G60 Device Name: CST-4 for use with OOD® one of fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Notes 2, 7, 8 |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E== added under Appendix E
#### Additional Comments:
Color Doppler meludes Power (Amplitude) Doppler
c onto Doppier medated in Net (Timpines) as C +P W. B+PD+PW, Dual Quad B, B+C, B+PD, B+DPD, B+DPD, B+DPD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes intertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neconatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hannonic Imaging (THI)
Note 8: 3D imaging
1. 1.31
ಡಿ
Note 9: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801 109)
hnd O Prescriptio
Indications for Use (Division Sign-Off)
**Division of Radiological Devices**
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### 510(k) No.: Device Name: C2-8 for use with UGEO G60 Device Name. Carol for aso with OSEA ging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note I | Notes 2, 7, 8 | |
| | Abdominal | P | P | P | | P | Note I | Notes 2. 7. 8 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging.<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note I | Notes 2. 7. 8 | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Supertic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N= new indication: P= previously cleared by FDA KI13381: E= added under Appendix E
#### Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Note 1: B-M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, Dual Quad B+C, B+PD, B+DPD
Note 2: Includes maging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediative and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
ence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Preseription Use (Per 21 CFR 801.109)
(Division Sign-Off)
IndicaDivision of Radiological Devices
510k K122582
{8}------------------------------------------------
## 510(k) No.: Device Name: CF4-9 for use with UGEO G60 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | 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<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Other (spec.) | | | | | | | | |
N= new indication: P= previously cleared by FDA K112339; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M. B+PW, B+C, B+PD, B+DPD. B+C+PW. B+DPD+PW, Dual Quad B, B+C, B+PD, B+DPD
Note 2: Includes maging for guidance of bropsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroxd, parathyroid, breast, scrotum and penis in adult, pediations and neconatal pattents
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TTII)
Note 8: 3D imaging
Note 9. Spatial Compound Imaging
teurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for
(Division Sign-Off)
Division of Radiological Devices
510(K) P2-QVR
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## 510(k) No.: Device Name: ER4-9 for use with UGEO G60 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 | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| (Track I only) | (Tracks 1 & III) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 8 | | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 8 | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Supertic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
N= new indication: P= previously cleared by FDA K092159: E= added under Appendix E
#### Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+C +PW, B+PD+PW, Dual Quad B, B+C , B+PD, B+DPD
Note 2: Includes maging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
currence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Preseription Use (Per 21 CFR 801.109)
Indications for Use (Division Sign-Off)
Division of Radiological Devices
{10}------------------------------------------------
## 510(k) No.: Device Name: EVN4-9 for use with UGFO G60 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<br>(Track 1 only) | Specific<br>(Tracks 1 & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& 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 | P | P | P | | P | Note 1 | Notes 2, 8 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 8 | |
| | 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<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N= new indication: P= previously cleared by FDA K 113381; E= added under Appendix E
### Additional Comments:
(`olor Doppler mcludes Power (^inplitude) Dopplet
Notel B+Ml B+PW, B+C , B+PD, B+DPD, B+C+PW, B+PD+PW, B+DPD-PW, Dual Quad B. B+C. B+PD, B+DPD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyrord, breast, scrown and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
urrence of CDIPH. Office of In Vitro Diagnostic Devices (OIVD) cription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications for Ugivision of Radiological Devices
510k Klaas 140
{11}------------------------------------------------
## 510(k) No.: Device Name: L5-13 for use with UGF.O G60 Intended Use: Diagnostic ultrasound imaging or tluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|--------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 | | |
| | Other (spec.) | | | | | | | | | |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B=PW, B+C, B+PD. B+DPD. B+C+PW, B+PD+PW, DualiQuad B+C, B+PD, B+DPD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediation and neonalial patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8-31) maging
Note 9: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) reseription Use (Per 21 CFR 801.109)
1 Prescription L
Indications for Use (Division Sign-Off)
Division of Radiological Devices
510k K122583
{12}------------------------------------------------
### 510(k) No.: Device Name: 3D2-6 for use with UGEO G60 Device Name: 332 v 101 site of this flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | Other |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|--------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication: P= previously cleared by FDA K100186; E= added under Appendix E
### Additional Comments:
Color Doppier meludes Power (Amplitude) Doppler
Color Doppier Mendes Fower (Ampindos) Dopper
Note 1: B+M, B=PW, B+C , B+PD, B+C -PW, B+PD+PW, B+PD+PW, B+DPD+PW, Dual Quad B, B+C', B+PD, B+DY'D
Note 2: Includes imaging for guidance of bropsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrown and pens in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Componnd Imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ications for
(Division Sign-Off)
Division of Radiological Devices
510K K022583 OIVD
{13}------------------------------------------------
### 510(k) No.:
## Device Name: VE4-8 for use with UGEO G60
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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal (See Note 3) | N | N | N | | N | Note 1 | Note 2, 7, 8 | | |
| | Abdominal | N | N | N | | N | Note 1 | Note 2, 7, 8 | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Note 2, 7, 8 | | |
| | 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<br>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+DPD, B+C+PW, B+PD+PW, Dual Quad B, B+C, B+PD, B+DPD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infectility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediative and
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
tric and neonatal patients
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
510K
{14}------------------------------------------------
### 510(k) No.:
## Device Name: 3D4-9 for use with UGEO G60
Intended Use: Diagnostic ultrasound imaging or thuid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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 | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | 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<br>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
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+DPD+PW, Dual/Quad B+C, B+PD, B+DPD
Note 2: Includes imaging for guidance of biopsy
Note 3: 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 neope
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
neonatal patients
(Division Sign-Off)
Office of In
510K K122583
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
