SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K061213 |
|---|---|
| Device Name | SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | May 16, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SONOACE PICO system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Musculoskeletal applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Device Story
SONOACE PICO is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays images in B-mode, M-mode, Color Doppler, Pulsed (PW) Doppler, Power Doppler, Harmonic imaging, and 3D imaging. Used in clinical settings by healthcare professionals for anatomical visualization and fluid flow analysis. The system provides on-screen thermal and mechanical indices for bioeffect monitoring. Output is viewed on an LCD monitor to assist clinicians in diagnosis and clinical decision-making, such as biopsy guidance or monitoring follicle development. Benefits include non-invasive diagnostic imaging across various clinical applications.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 60601-1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, and ISO 10993 for biocompatibility. No clinical data was required for this 510(k) clearance.
Technological Characteristics
Mobile diagnostic ultrasound system. Materials comply with ISO 10993. Employs ultrasonic pulsed echo and Doppler imaging. Connectivity includes LCD display. Software-controlled. Complies with NEMA UD 2-2004 and UD 3-2004 for acoustic output and thermal/mechanical indices. Sterilization method not specified.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-urethral, trans-esophageal, musculoskeletal, cardiac, and peripheral vessel applications. Includes guidance for biopsy and infertility monitoring. Prescription use only.
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
- SA8000 Ultrasound system (K013627)
- SA8000 SE Ultrasound system (K043455)
Reference Devices
Related Devices
- K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jul 16, 2010
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
- K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 5, 2011
- K150050 — ACUSON P500 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 9, 2015
- K210743 — ACUSON Redwood Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Apr 1, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
# SONOACE PICO Diagnostic
MAY 16 2006
### 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)
Medison Co. Ltd. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager
| Telephone: | 82.2.2194.1381 |
|------------|--------------------|
| Facsimile: | 82.2.2194.1399 |
| Email: | kashim@medison.com |
Data Prepared: April 10, 2006
### 2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SONOACE PICO Diagnostic Ultrasound System
| Classification Names: | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
### 3. Identification of the predicate or legally marketed device:
K013627, 11/16/2001, SA8000 Ultrasound system K043455, 12/21/2004, SA8000 SE Ultrasound system
. .. ..
### 4. Device Description:
The SONOACE PICO is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color Doppler, Pulsed (PW) Doppler, Power Doppler, Harmonic imaging and 3D imaging , or as a combination of these modes on the LCD monitor.
510(k) Summary of Safety and Effectiveness
ATTACHMENT 1(b)
{1}------------------------------------------------
The SONOACE PICO has 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 y -
- -NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- -NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output .
- -ISO10993, Biocompatibility
#### 5. Intended Uses:
The SONOACE PICO system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Musculoskeletal applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
#### 6. Technological Characteristics:
The SONOACE PICO is substantially equivalent to the SA8000 Diagnostic Ultrasound System, cleared via K013627, and the SA8000 SE Diagnostic Ultrasound System, cleared via K043455. 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 of Safety and Effectiveness
.. .. . . . . .
ATTACHMENT 1(b)
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### MAY 1 6 2006
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K061213
Trade Name: SONOACE PICO Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: April 27, 2006 Received: May 2, 2006
#### Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE PICO Ultrasound System, as described in your premarket notification:
Image /page/2/Picture/11 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are displayed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned beneath it. The text "FDA 100 YEARS OF CONSUMER PROTECTION" is arranged around the circular border of the logo.
{3}------------------------------------------------
#### Transducer Model Number
| -<br>(<br>1<br> | AND A . A . A . An . BEACH SECTION<br>1 | LELELE ANNUAL IS LEALERIES & SEA |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 1<br>Andrew | -<br>A bentlette disting<br>10.00<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1<br>1<br>And And And Company And And And And And And Children |
| 1<br> | A 40 1<br>No. of Cattle Catal<br><br>more of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the co | .<br>1 |
| | AND AND AND<br>And section the different to the desires of the de | |
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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device. vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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.
{4}------------------------------------------------
Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace Eacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter; please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours,
Nancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
### Section 4.3 INDICATIONS FOR USE
### DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
061213 510(k) No .:
Device name: SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation General Specific B M PWD CWD Color Combined* Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (Soo Note 3) P P P P Note 1 Nate 7 6 7 8 Abdominal P P P P Note 1 Note 2, 6, 7, 8 Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric P P P P Note l Note 2, 5, 7, 8 P P P Small Organ (See Note 5) P Note 1 Note 2, 5, 8 N N Neonatal Cephalic N N Note l Note 2, 5, 8 Adult Cephalic P P Trans-rectal P P Note 2, 8 Note 1 Trans-vagina! P P P b Note 2, 3, 8 Note l Trans-urethral Trans-esoph. (non-Cardiac) P P Musculo-skel. (Convent.) P P Notel Note 2, 5, 8 Musculo-skel. (Superfic.) P P P P Note I Note 2, 5, 8 Intra-luminal Other (spec.) P Cardian Adult P P P Notel Note 4 Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Perinheral veccal Perinheral P P P P Notel Note 7 5 8 Vessel Other (spec.)
N= new indication; P= previously cleared by FDA in K031552; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) D
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061213
Section 4.3, Page 1 of 12
{6}------------------------------------------------
#### Kob 1213 510(k) No.: C2-4ES with SONOACE PICO Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------|-------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 | Note 2, 7, 8 |
| | Abdominal | N | N | N | | N | Note 1 | Note 2, 7, 8 |
| | Intra-operative<br>(Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 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 | P | P | P | | P | Note 1 | Note 4 |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K031552; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy broadon
Basic Information
Section 4.3, Page 2 of 12
{7}------------------------------------------------
510(k) No.:
K061213
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
| | Device name: C2-5ET with SONOACE PICO Ultrasound System | | | | | | | |
|---------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Clinical Application | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>Mode of Operation | | | | | | |
| 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 | P | Note 1 | Note 2, 7, 8 |
| | Abdominal | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative<br>(Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| & Other | Pediatric | P | 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 | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K043455; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
- 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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Brigdon
一、大量的一系的意味
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061213
Section 4.3, Page 3 of 12
{8}------------------------------------------------
#### 510(k) No .: Device name: th SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------|-------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 | Note 2, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (Abdominal, vascular) | | | | | | | |
| | 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.) | | | | | | | |
| Perinheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K013627, K031552, K043455; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
510kl
Section 4.3, Page 4 of 12
{9}------------------------------------------------
#### KO61213 510(k) No .:
### Device name: C4-7ED with SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------|--|-------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 2) | | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Abdominal | | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative<br>(Abdominal,<br>vascular) | | | | | | | | |
| | 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.) | | | | | | | | |
| Perinheral<br>Vessel | Perinheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA in K990970, K012887; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061213
Section 4.3, Page 5 of 12
{10}------------------------------------------------
| 510(k) No .: | K061213 | A | | | | | | |
|----------------|--------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|----------|-----------|-----------------|
| Device name: | C4-9ED with SONOACE PICO Ultrasound System | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| | Clinical Application | | Mode of Operation | | | | | |
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 2) | P | P | P | | P | Note 1 | Note 2 6 7 8 |
| | Abdominal | N | N | N | | N | Note 1 | Note 2, 6, 7, 8 |
| | Intra-operative<br>(Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| & Other | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 8 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 2, 5, 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 | Peripheral vessel | P | P | P | | P | Note 1 | Note 2 5 8 |
| Vessel | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K043455; E= added under Appendix E Additional Comments:
#### Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
- 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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Section 4.3, Page 6 of 12
.
{11}------------------------------------------------
KO61213 510(k) No .:
### Device name: EC4-9ED with SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation CWD General Specific B M PWD Color Combined* Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (Soo Note 3) Abdominal Intra-operative (Abdominal, vascular) Intra-operative (Neuro.) Laparoscopic Fetal Imaging Pediatric & Other Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal P P P P Note 1 Note 2, 8 P Trans-vaginal P P P Note I Note 2, 3, 8 Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardian Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Perinheral Perinheral vescel Vessel Other (spec.)
N= new indication; P= previously cleared by FDA in K031552, K043455; E=added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler/PWD, B/Power Doppler/PWD, B/Power Doppler/PWD
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, 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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
Basic Information
(Division Sic Division of Reproductiv and Radiological Devices 510(k) Number
Section 4.3, Page 7 of 12
{12}------------------------------------------------
#### KO61218 510(k) No.:
### Device name: EC4-9ES with SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------|---|-------------------|-----|-----|-------------------|----------------------|------------------|--|
| 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<br>(Abdominal,<br>vascular) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 8 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 3, 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 in K031552, K013627; E=added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
and Rad 510(k) Numb
Section 4.3, Page 8 of 12
{13}------------------------------------------------
| 510(k) No.: | K061213 | | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| | Device name: HC2-5ED with SONOACE PICO Ultrasound System | | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | | |
| 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 | Note1 | Note 2 8 | |
| | Abdominal | P | P | P | | P | Note1 | Note 2, 8 | |
| | Intra-operative (Abdominal,<br>vascular) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note1 | Note 2, 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.) | | | | | | | | |
| Perinheral<br>Vessel | Peripheral vessel<br>Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA in K031552; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Broadon
Basic Information
(Division Sio Division of Reproductive and Radiological Devices 510(k) Number
Section 4.3, Page 9 of 12
{14}------------------------------------------------
510(k) No.:
### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
### KO61213
Device name: HL5-9ED with SONOACE PICO Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application<br>Mode of Operation | | | | | | | |
|---------------------------|---------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| 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 ( <i>See Note 3</i> ) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Small Organ ( <i>See Note 5</i> ) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | 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, 8 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Perinheral<br>Vessel | Perinheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K013627, K031552, K043455; E= added under Appendix E Additional Comments:
#### Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
- 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
Basic Information
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Division of Reproductive, Abde and Radiological Devices 510(k) Number
Section 4.3, Page 10 of 12
{15}------------------------------------------------
| 510(k) No.: | K061213 | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device name: | L5-9EC with SONOACE PICO Ultrasound System | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | |
| 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 (Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | 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, 8 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2 & 8 |
| | Other (spec.) | | | | | | | |
| Vessel | Other (spec.) |
|--------|---------------|
|--------|---------------|
N= new indication; P= previously cleared by FDA in K013627; E= added under Appendix E
Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Power Doppler, B/Color Doppler/PWD, B/Power Doppler/PWD
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
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C Broadon
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Section 4.3, Page 11 of 12
{16}------------------------------------------------
| K061213<br>510(k) No.: | | | | | | | | |
|---------------------------------------------------------|---------------------------------------------|---|--------------------------------------------------------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| Device name: L5-9EE with SONOACE PICO Ultrasound System | | | | | | | | |
| | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
| | Clinical Application | | Mode of Operation | | | | | |
| 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<br>(Abdominal,<br>vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 8 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
|…
