SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K063580 |
|---|---|
| Device Name | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 14, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SONOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Pediatric Cardiology, TCD, Cardiac, Small parts, Vascular, Muscularskeletal, Pediatric Abdomen, OB, Gynecology, Urology, Pediatric Cardiac, Adult Cardiac, Pediatric and Appendix applications.
Device Story
SONOACE X8 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in 2D, M-mode, Color/Power Doppler, Harmonic imaging, and PW/CW Spectral Doppler modes. It also supports 3D imaging using mechanical scan probes. Operated by healthcare professionals in clinical settings, the system performs real-time acoustic output display (mechanical and thermal indices) and provides measurement/analysis packages for anatomical structures and fluid flow. Output is viewed on a CRT display to assist clinicians in diagnostic decision-making. The system benefits patients by enabling non-invasive visualization of internal structures and hemodynamics.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157, and ISO 10993 for biocompatibility.
Technological Characteristics
Mobile diagnostic ultrasound system. Materials comply with ISO 10993. Sensing via ultrasonic pulsed echo and Doppler. Energy source: electrical. Connectivity: standard ultrasound interface. Software-controlled. Sterilization: N/A (transducers are reusable/patient-contact). Safety standards: UL 60601-1, IEC 60601-2-37, NEMA UD 2/3.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients. Clinical applications include: Fetal, Abdominal, Pediatric, Small Organ (thyroid, parathyroid, breast, scrotum, penis), Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (conventional/superficial), Cardiac (adult/pediatric), and Peripheral vessel. Includes guidance for biopsy and infertility monitoring.
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 XQ Diagnostic Ultrasound System (K052911)
- SA8000 Diagnostic Ultrasound System (K013627)
Related Devices
- K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 10, 2009
- K052911 — ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Oct 31, 2005
- K053530 — SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 3, 2006
- K102065 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Aug 6, 2010
- K081676 — SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jul 2, 2008
Submission Summary (Full Text)
{0}------------------------------------------------
DEC 1 4 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: October 25, 2006
#### 2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SONOACE X8 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:
K052911, 10/31/2005, ACCUVIX XQ Diagnostic Ultrasound System K013627, 11/16/2001, SA8000 Diagnostic Ultrasound System
#### 4. Device Description:
The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode.
The SONOACE X8 has real time acoustic output display with two basic indices, a
510(k) Summary of Safety and Effectiveness
{1}------------------------------------------------
mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
The SONOACE X8 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 v
- 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 X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
Abdomen, Pediatric Cardiology, TCD, Cardiac, Small parts, Vascular, Muscularskeletal, Pediatric Abdomen, OB, Gynecology, Urology, Pediatric Cardiac, Adult Cardiac, Pediatric and Appendix applications.
#### 6. Technological Characteristics:
The SONOACE X8 is substantially equivalent to the ACCUVEX XQ Diagnostic Ultrasound System, cleared via K052911, and the SA8000 Diagnostic Ultrasound System, cleared via K013627. 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
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K063580
Trade Name: SONOACE X8 Diagnostic 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: November 27, 2006 Received: November 30, 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.
DEC 1 4 2006
This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE X8 Diagnostic Ultrasound System, as described in your premarket notification:
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular and contains the letters "FDA" in the center. The text "1906-2006" is at the top of the logo. The words "Protecting and Promoting Public Health" are written in a fancy font below the logo.
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#### Transducer Model Number
| 3D2-5EH | C2-5EL | L5-12EC |
|---------|------------|---------|
| 3D2-5EL | C3-7EP | P2-4AC |
| 3D2-6ET | C4-9/10ED | P2-4AH |
| 3D4-8EK | NER4-9ES | P3-5AC |
| 3D4-8ET | NEV4-9ES | P3-7AC |
| 3D4-9ES | HL5-12ED | CW 2.0 |
| 3D5-9EK | L4-7EH | CW 4.0 |
| C2-4ES | L5-12/50EP | |
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 (OS) 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, you 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
{4}------------------------------------------------
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 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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 at (240) 276-3666.
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
Enclosure(s)
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## Section 4.3 INDICATIONS FOR USE
| DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT | | | | | | | |
|--------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|------------------------------------------|
| 510(k) No.: K063580 | | | | | | | |
| Device Name: SONOACE X8 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.)<br>Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | |
| | Fetal (See Note 3) | N | N | N | N | N | Note 1<br>Notes 2, 7, 8 |
| | Abdominal | N | N | N | N | N | Note 1<br>Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1<br>Note 2,4,5,6,7,8,9 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1<br>Note 2,5,6,8,9 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 |
| | Adult Cephalic | N | N | N | N | N | Note 1<br>Note 4, 7 |
| | Trans-rectal | N | N | N | N | N | Note 1<br>Note 2, 3, 8 |
| | Trans-vaginal | N | N | N | N | N | Note 1<br>Note 2, 3, 8 |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1<br>Note 2,5,6,8,9 |
| | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1<br>Note 2,5,6,8,9 |
| | Intra-luminal | | | | | | |
| | Other (spec.) | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1<br>Note 4, 7 |
| | Cardiac Pediatric | N | N | N | N | N | Note 1<br>Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1<br>Note 5, 6, 9 |
| | Other (spec.) | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
,
00/AX00/VCJ
Nancy Brogdon
(Division Siring Division of Reproductive, I and Radiological Devices 51()(k) Number _______________________________________________________________________________________________________________________________________________________________
{6}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D2-5EHfor use with SONOACE X8 | | | | | | | | |
| 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) | | | | | | | |
| | | 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.) | | | | | | | |
new indication; P= previously cleared by FDA: added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
Nancy C. Swogdon
(Division Sign-Off Division of Reproductive, Al and Radiological Devices 510(k) Number __
{7}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D2-5ELfor use with SONOACE X8 | | | | | | | |
| 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) | 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 includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
Nancy C Broadon
(Division Sign-Off)
Division of Reproductive, Abdg and Radiological Devices 510(k) Number
{8}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D2-6ET for use with SONOACE X8 | | | | | | | |
| 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) | 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) | | | | | | | |
| Fetal Imaging<br>& Other | Intra-operative (Neuro.) | | | | | | | |
| | 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 | | | | | | | |
| Cardiac | Other (spec.) | | | | | | | |
| | 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/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
{9}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D4-8EK for use with SONOACE X8 | | | | | | | | |
| 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) | 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 | 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/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580
{10}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | 3D4-8ET for use with SONOACE X8 | | | | | | | | |
| 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 | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | 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 | 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/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD
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: Panoramic imaging
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580
{11}------------------------------------------------
#### KO63580 510(k) No.: Device Name: 3D4-9ES for use with SONOACE X8 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 Combined* Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Notes 2, 8 N N N Note l N Trans-vaginal N Notes 2, 8 N N N Note 1 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; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD
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: Panoramic imaging
#### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
VV063580
510(k) Number
{12}------------------------------------------------
| 510(k) No.: | K063580 |
|---------------|------------------------------------------------------------------------------------|
| Device Name: | 3D5-9EK for use with SONOACE X8 |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
|---------------------------|---------------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|--|
| | Clinical Application | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| & Other | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | Note 1 | Notes 2, 8 | |
| | Trans-vaginal | N | N | N | | N | 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; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K1106580
{13}------------------------------------------------
# 2063580
510(k) No .: C2-4ES for use with SONOACE X8 Device Name:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| 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 ( <i>See Note 3</i> ) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | | |
| | 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 | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| | 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/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD
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: Panoramic imaging
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K063580
{14}------------------------------------------------
| 510(k) No.: | K063580 | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | C2-5EL for use with SONOACE X8 | | | | | | | |
| 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) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal |…
