H60 V2.00 Diagnostic Ultrasound System
Device Facts
| Record ID | K143264 |
|---|---|
| Device Name | H60 V2.00 Diagnostic Ultrasound System |
| Applicant | Samsung Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 9, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The H60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Device Story
H60 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in various modes: B-mode, Color/Power Doppler (including S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Operated by healthcare professionals in clinical settings, the device provides anatomical measurements and analysis packages to assist in diagnosis. It features real-time acoustic output display (mechanical and thermal indices). The system processes received echoes to generate on-screen images of internal structures and fluid flow. Clinical benefits include non-invasive visualization and guidance for procedures like biopsies and infertility monitoring.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output measurements, biocompatibility (ISO 10993-1), and electrical/mechanical safety testing (IEC 60601 series).
Technological Characteristics
Mobile ultrasound system using linear, curved, endocavity, and phased array transducers (1.0–20.0 MHz). Employs ultrasonic pulsed Doppler and echo imaging. Features include B-mode, M-mode, PW/CW Doppler, Color/Power Doppler, Tissue Harmonic Imaging, 3D/4D, and Elastoscan. Patient contact materials tested per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-2-37, and NEMA UD-2/UD-3 standards.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis in fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel applications.
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
- UGEO H60 Diagnostic Ultrasound System (K132861)
- RS80A Diagnostic Ultrasound System (K141620)
- UGEO WS80A Diagnostic Ultrasound System (K133329)
- UGEO PT60A Diagnostic Ultrasound System (K142466)
Related Devices
- K170493 — HS50 / HS60 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Mar 28, 2017
- K122583 — UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Sep 5, 2012
- K163691 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Feb 22, 2017
- K152962 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Nov 2, 2015
- K171000 — P60 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Jul 11, 2017
Submission Summary (Full Text)
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Image /page/0/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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SAMSUNG MEDISON CO., LTD C/O MARK JOB 1394 25TH STREET, NW BUFFALO MN 55313
December 9, 2014
Re: K143264
Trade/Device Name: H60 V2.00 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: November 12, 2014 Received: November 13, 2014
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 Industry and Consumer Education at its toll-free number (800) 638 2041
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Page 2-Mr. Job
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K143264
Device Name
H60 Diagnostic Ultrasound System
The H60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) No.:
Device Name: H60 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<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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11, 12 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Note 2, 4, 5, 6, 7, 8, 9, 11 | |
| | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Note 2, 7, 8, 11 | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 12 | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{4}------------------------------------------------
## 510(k) No.:
### Device Name: CS1-4 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 | |
| | 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.) (See Note 13) | | | | | | | | |
| | 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
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## 510(k) No.:
#### Device Name: C2-8 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | 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.) (See Note 13) | | | | | | | |
| 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{6}------------------------------------------------
## 510(k) No.:
### Device Name: CF4-9 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2, 7, 8, 11 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{7}------------------------------------------------
## 510(k) No.:
### Device Name: ER4-9 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| &<br>Other | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 8, 12 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 8, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 8, 12 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{8}------------------------------------------------
### 510(k) No.:
#### Device Name: EVN4-9 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Abdominal (See Note 10) | | | | | | | |
| | 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, 12 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 8, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 8, 12 |
| | 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{9}------------------------------------------------
# 510(k) No.:
### Device Name: L5-13 for use with H60
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/Obstetrics (See Note 3) | | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | | |
| | 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, 11 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | |
| | 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, 11 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | | | |
| | 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, 11 | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{10}------------------------------------------------
## 510(k) No.:
### Device Name: 3D2-6 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 4, 7, 8, 11 | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 | | |
| | 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.) (See Note 13) | | | | | | | | | |
| | 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{11}------------------------------------------------
### 510(k) No.:
### Device Name: VE4-8 for use with H60
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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 4, 7, 8, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 |
| | 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.) (See Note 13) | | | | | | | |
| 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{12}------------------------------------------------
# 510(k) No.:
### Device Name: 3D4-9 for use with H60
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/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, | |
| | Abdominal (See Note 10) | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| & Other | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 12 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 12 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 8, 12 | |
| 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
{13}------------------------------------------------
## 510(k) No.:
### Device Name: CF2-8 for use with H60
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/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | |
| | 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.) (See Note 13) | | | | | | | | |
| | 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 K132861; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, 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 neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan Note 13: Includes Urology/Prostate
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
{14}------------------------------------------------
### 510(k) No.:
### Device Name: LF5-13 for use with H60
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/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) |…
