SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K053530 |
|---|---|
| Device Name | SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 3, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SONOACE X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, 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 X4 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays images in 2D (B) mode, M mode, Power Doppler, Harmonic imaging, or 3D imaging on a CRT display. Operated by clinicians in clinical settings, the device provides anatomical measurements and analysis packages to assist in clinical diagnosis. The system processes received echoes to visualize structures and fluid flow. It includes thermal and mechanical indices for bioeffect monitoring. Benefits include non-invasive visualization and diagnostic support for various anatomical regions.
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; CRT display; supports 2D (B), M, Power Doppler, Harmonic, and 3D imaging modes. Complies with NEMA UD 2-2004 and UD 3-2004 for acoustic output and thermal/mechanical indices. Biocompatibility per ISO 10993. Software-controlled signal processing.
Indications for Use
Indicated for ultrasound imaging and fluid flow analysis in adult, pediatric, and neonatal patients across clinical applications including fetal, abdominal, intra-operative, small organ (thyroid, breast, scrotum, penis), neonatal/adult cephalic, cardiac, trans-rectal, trans-vaginal, and peripheral vascular. Includes guidance for biopsy.
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
- SA6000II Ultrasound system (K012887)
- SA8000SE Ultrasound system (K043455)
Related Devices
- K063580 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 14, 2006
- K061946 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jul 21, 2006
- K103397 — ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Feb 25, 2011
- K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 10, 2009
- K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 5, 2011
Submission Summary (Full Text)
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K053530
#### 2006 JAN 3
510(k) Premarket Notification
SONOACE X4 Diagnostic Ultrasound System
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
### 1. Submitter's Information: 21 CFR 807.92(a)(1)
Medison Co. Ltd. 997-10, 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:
November 10, 2005
# 2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
## Proprietary Name:
SONOACE X4 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:
K012887, 09/12/2001, SA6000II Ultrasound system K043455, 12/21/2004, SA8000SE Ultrasound system
## 4. Device Description:
The SONOACE X4 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 2D (B) mode, M mode, Power Doppler imaging, Harmonic imaging, or 3D imaging on the CRT display.
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The SONOACE X4 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 X4 system is intended for the following applications: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Vascular, 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 X4 is substantially equivalent to the SA6000II Diagnostic Ultrasound System, cleared via K012887, 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison C., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K053530
Trade Name: SONOACE X4 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: December 15, 2005 Received: December 19, 2005
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 X4 Diagnostic Ultrasound System, as described in your premarket notification:
### Transducer Model Number
| HL5-9ED | L5-9EC | L5-9EE |
|---------|---------|---------|
| C2-4ES | C2-5ET | C3-7ED |
| C4-9ED | EC4-9ED | EC4-9ES |
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# Page 2 - Mr. Mark Job
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) OF N F 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) commins anaseeptarre ratus () goduction 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 r ne speerly 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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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Page 3 - Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Mr. Rodrigo Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Chapman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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### 510(k) Number:
# Device Name: SONOACE X4 Diagnostic Ultrasound System
Device Name: "OONOROE A Diag fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Abdominal | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Intra-Operative<br>(See Note 4) | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Small Organ<br>(See Note 2) | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Neonatal Cephalic | | N | N | N | | | | | Notes 1 | Note 5 |
| Adult Cephalic | | N | N | N | | | | | Notes 1 | Note 5 |
| Cardiac | | N | N | N | | | | | Notes 1 | Note 5 |
| Transesophageal | | | | | | | | | Notes 1 | |
| Trans-Rectal | | N | N | N | | | | | Notes 1 | Notes 3, 5 |
| Trans-Vaginal | | N | N | N | | | | | Notes 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | N | | | | | Notes 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Muscular-Skeletal<br>Superficial | | N | N | N | | | | | Notes 1 | Notes 3, 5, 6 |
| Others(Specify) | | | | | | | | | | |
#### Mode of Operation
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. B/M, B/P W Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Donald C. Hodgson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
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#### 510(k) Number:
# 510(K) Namber .
Device Name: HL5-9ED for use with SONOACE X4
Device Name: HC9-5ED for use with SONONONOSA
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative<br>(See Note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | Note 1 | Notes 3, 5 |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Small Organ<br>(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | P | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal<br>Superficial | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |
Mode of Oneration
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1: B/M, B/PVV Doppler
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel H. Ingram
(Division Sian-O Division of Reproductive, Abdo and Radiological Device 510(k) Number
{7}------------------------------------------------
#### 510(k) Number:
Device Name: L5-9EC for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative<br>(See Note 4) | P | P | P | N | | | | | Note 1 | Notes 5 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Small Organ<br>(See Note 2) | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | P | P | P | N | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal<br>Superficial | P | P | P | N | | | | | Note 1 | Notes 3, 5 |
| Others (Specify) | | | | | | | | | | |
# Mode of Operation
N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for quidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Lynn
(Division Sion-Of Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
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#### 510(k) Number:
Device Name: L5-9EE for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative<br>(See Note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Small Organ<br>(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | P | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal<br>Superficial | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |
# Mode of Operation
N = new indication; P = previously cleared in K043455 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David h. Sungum
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
{9}------------------------------------------------
#### 510(k) Number:
# Device Name: C2-4ES for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | N | | | | | Note 1 | Note 5 |
| Abdominal | | P | P | N | | | | | Note 1 | Note 5 |
| Intra-Operative<br>(See Note 4) | | P | P | N | | | | | Note 1 | Note 5 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | N | | | | | Note 1 | Note 5 |
| Small Organ<br>(See Note 2) | | P | P | N | | | | | Note 1 | Note 5 |
| Neonatal Cephalic | | P | P | N | | | | | Note 1 | Note 5 |
| Adult Cephalic | | P | P | N | | | | | Note 1 | Note 5 |
| Cardiac | | P | P | N | | | | | Note 1 | Note 5 |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | N | | | | | Note 1 | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |
Modo nf Anarating
N = new indication; P = previously cleared in K012887 ; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1: Dhi, Dr. V. Doppier
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David A. Johnson
(Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices 510(k) Number
{10}------------------------------------------------
510(k) Number:
Device Name: C2-5ET for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Note 5 |
| Abdominal | | P | P | P | | | | | Note 1 | Note 5 |
| Intra-Operative<br>(See Note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | | | | Note 1 | Note 5 |
| Small Organ<br>(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |
Mode of Oneration
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. Diw, Dr. V. Doppic.
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel H. Leyton
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
{11}------------------------------------------------
#### 510(k) Number:
Device Name: C3-7ED for use with SONOACE X4
Device Name: "Oo read imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5, 6 |
| Abdominal | | P | P | P | | | | | Note 1 | Notes 3, 5, 6 |
| Intra-Operative<br>(See Note 4) | | P | P | N | | | | | Note 1 | Notes 5, 6 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5, 6 |
| Small Organ<br>(See Note 2) | | P | P | N | | | | | Note 1 | Notes 3, 5, 6 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | N | | | | | Note 1 | Notes 3, 5, 6 |
| Muscular-Skeletal<br>Superficial | | P | P | N | | | | | Note 1 | Notes 3, 5, 6 |
| Others(Specify) | | | | | | | | | | |
# Mode of Oneration
N = new indication; P = previously cleared in K012887 & K043455 ; E = added under Appendix E Additional Comments:
### Note 1: B/M, B/PW Doppler
Note 1. Diw, Dri VV Dopper
Note 2: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Symm
---
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{12}------------------------------------------------
#### 510(k) Number:
Device Name: C4-9ED for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (See Note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | P | P | P | | | | | Note 1 | Notes 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Vaginal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |
# Mode of Operation
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 1. BM, and W Dopplic patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David K. Ingram
(Division Sian-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Numbe
Prescription Use (Per 21 CFR 801.109)
Section 4.3, Page 8
{13}------------------------------------------------
#### 510(k) Number:
### Device Name: EC4-9ED for use with SONOACE X4
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Abdominal | | | | | | | | | | |
| Intra-Operative<br>(See Note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Vaginal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral-Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Mode of Operation
N = new indication; P = previously cleared in K043455; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
David R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
{14}------------------------------------------------
## 510(k) Number:
510(K) Nambor:
Device Name: EC4-9ES for use with SONOACE X4
Device Name: "EO4-5ES for ass w rated with thow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler* | Power<br>(Amp)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Spec.) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|---------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Abdominal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative<br>(See Note 4) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Small Organ<br>(See Note 2) | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Neonatal Cephalic | | P | P | P | | | | | Note 1 | Notes 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Vaginal | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Muscular-Skeletal<br>Superficial | | P | P | P | | | | | Note 1 | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |
### Mode of Operation
N = new indication; P = previously cleared in K012887; E = added under Appendix E Additional Comments:
Note 1: B/M, B/PW Doppler
Note T. B/W, B/F W Doppler
Note 2: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 3: Includes imaging for guidance of biopsy
Note 4: Abdominal organs and peripheral vessel
Note 5: 3D Imaging
Note 6: Harmonic Imaging
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel R. Leyton
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
