(15 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML technology in the device description, intended use, or any other section.
No.
A therapeutic device is used for treatment, whereas this device is explicitly stated to be for "diagnostic ultrasound imaging and fluid analysis of the human body."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic ultrasound imaging" and the "Device Description" section identifies it as a "diagnostic ultrasound system" that provides "information used for clinical diagnostic purposes". Additionally, all listed predicate devices are identified as "Diagnostic Ultrasound System".
No
The device is described as a "general purpose, mobile, software controlled, diagnostic ultrasound system." It explicitly mentions "system and transducers" and describes its function as acquiring ultrasound data and displaying it, which inherently involves hardware components (the ultrasound machine and transducers) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging system used to visualize internal structures and potentially analyze fluids within the body, not to perform tests on samples outside the body.
- Device Description: The description focuses on the system's ability to acquire and display ultrasound data in various modes (B mode, M mode, Doppler, etc.) and provide measurements and analysis packages for clinical diagnostic purposes. This is consistent with an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (outside the living organism).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system is used for direct imaging and analysis in vivo.
N/A
Intended Use / Indications for Use
The SONOACE X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The SONOACE X6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes on the LCD display.
The SONOACE X6 has real time acoustic output display with two basic indices, a 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, Fetal, Abdominal, Pediatric, Small Organ (e.g. thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Convent.), Musculo-skeletal (Superfic.), Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Abdominal organs.
Indicated Patient Age Range
Adult, pediatric, neonatal patients, fetal.
Intended User / Care Setting
Competent health care professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
1681676
SONOACE X6 Diagnostic Ultrasound System
JUL - 2 2008 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: May 15, 2008
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SONOACE X6 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:
K043455, 12/21/2004, SA8000 SE Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System
4. Device Description:
The SONOACE X6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes on the LCD display.
1
The SONOACE X6 has real time acoustic output display with two basic indices, a 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 X6 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
- 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 X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.
6. Technological Characteristics:
The SONOACE X6 is substantially equivalent to the SA8000 SE Diagnostic Ultrasound System, cleared via K043455, and the SONOACE X8 Diagnostic Ultrasound System, cleared via K063580. 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
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of three abstract shapes resembling birds in flight, arranged in a diagonal line.
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: K081676
Trade/Device Name: SONOACE X6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 16, 2008 Received: June 17, 2008
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.
JUL - 2 2008
This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE X6 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C3-7EP |
|---|
| C4-9ED |
| NER4-9ES |
| NEV4-9ES |
| HL5-12ED |
| L5-12/50EP |
3
| 1
| 1 | I |
|---|---|
| 177 | D |
- |
| ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ | / - |
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, 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, Marvland 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
4
:
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Arqui M. Whang
S Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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5
Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No .: Device Name:
SONOACE X6 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 | Specific | B | M | PWD | CWD | Color | ||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| 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.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2,4,5,6,7,8 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6,8 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | ||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 3, 7, 8 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 7, 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2,5,6,8 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2,5,6,8 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5 6 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW 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: Harmonic Imaging
Note 8: 3D imaging
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological De 510(k) Number
6
510(k) No .:
Device Name: C3-7EP for use with SONOACE X6
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 | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (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 | ||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (See Note 6) | |||||||
| Intra-operative (Neuro.) | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color, B/PD, B/Color/Color M, B/Color/Color M, B/Color/Steered CW, B/Steered CW 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: Harmonic Imaging
Note 8: 3D imaging
Homi Ta Wiz
(Division Sian-C ductive. Abdominal and Division of Re Radiological De 510(k) Number
7
510(k) No .:
| Device Name:
| C4-9ED for use with SONOACE X6 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | P | P | P | P | Note 1 | Note 2, 8 | ||||
| Small Organ (See Note 5) | |||||||||||
| Neonatal Cephalic | P | P | P | P | Note 1 | Note 2, 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 8 | ||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color/PW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW 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: Harmonic Imaging
Note 8: 3D imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Torque Tn Why
ian-Off (Division Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
8
510(k) No .:
| Device Name:
| NER4-9ES for use with SONOACE X6 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| (Track I only) | (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal (See Note 3) | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (See Note 5) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/ColorPW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW 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: Harmonic Imaging
Note 8: 3D imaging
how to write
Division 510/k) N
9
510(k) No .:
| NEV4-9ES for use with SONOACE X6 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | ||||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
Lorry M. Witz
(DivisionSign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081626
10
510(k) No.:
Device Name: HL5-12ED for use with SONOACE X6
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 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 P P Note 2, 5, 6 P P Note l Small Organ (See Note 5) P P P P Note 1 Note 2, 5, 6 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) P P P Note 2, 5, 6 P Note 1 Musculo-skel. (Superfic.) P P P Note 2, 5, 6 P Note l Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel P P p P Note 1 Note 5, 6 Vessel Other (spec.)
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
Aornai In Wty
11
510(k) No.:
Device Name: L5-12/50EP for use with SONOACE X6 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 | |||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| (Track I only) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6 | |||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 5, 6 | ||
| Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
Signature
Division o Radiologi 510/k) N
12
510(k) No .:
Device Name: P2-4AH for use with SONOACE X6
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 P P P P P Note l Note 4, 7 Intra-operative (See Note 6) Intra-operative (Neuro.) Laparoscopic Fetal Imaging & Other Pediatric Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic P P p P P Note 1 Note 4, 7 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 Note I P Note 4 7 Cardiac Cardiac Pediatric p P P P P Note 1 Note 4, 7 Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color, B/PD, B/Color/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
Dorge In Wly
Division Sign-Off
13
510(k) No .:
| CW 2.0 for use with SONOACE X6
| Device Name: | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW, B/Color/PW, B/PD/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
Vorquita White
(Division S! ប្រទេទ្រ
14
510(k) No .:
Device Name: CW 4.0 for use with SONOACE X6
| Device Name: | CV-4.0 for use with SONOACE X6 | |
|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |
| Clinical Application | Mode of Operation (*includes simultaneous B mode) |
| 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 | P | ||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | ||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K063580; E=added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BM, B/PW, B/Color, B/PD, B/Color/PW, B/PD/PW, B/Color/Color M, B/Color/Steered CW, B/Steered CW
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: Harmonic Imaging
Note 8: 3D imaging
_
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