(12 days)
No
The document describes standard ultrasound imaging modes and post-processing techniques without mentioning AI or ML. The lack of information on training/test sets and performance metrics further supports this conclusion.
No
The device is described as a "diagnostic ultrasound system" and its function is to acquire and display ultrasound data for "clinical diagnostic purposes," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic ultrasound imaging." Additionally, the "Device Description" section identifies the ACCUVIX V7 as a "diagnostic ultrasound system" and mentions that its analysis packages provide information "used for clinical diagnostic purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions transducers and probes, which are hardware components essential for acquiring ultrasound data. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes a device that images structures within the body using ultrasound waves.
- Device Description: The description details how the system acquires and displays ultrasound data as various imaging modes. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: An IVD device is designed to perform tests on samples taken from the human body (like blood, urine, tissue). There is no mention of sample analysis or testing of biological specimens in the provided text.
The device is a diagnostic ultrasound system used for imaging the internal structures of the body, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The ACCUVIX V7 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: General, Obstetrics, Gynecology, Extremity, Urology, Breast. Renal, Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo, Carotid, Varicose, Fetal Abdominal, Small organ, Intra-operative, Cephalic, Muscular-skeletal, Trans-rectal, Trans-vaginal, Contrast Agent, Transesophageal and Peripheral-vascular applications.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The ACCUVIX V7 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 ACCUVIX V7 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 ACCUVIX V7 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 y
- 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General, Obstetrics, Gynecology, Extremity, Urology, Breast, Renal, Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo, Carotid, Varicose, Fetal Abdominal, Small organ, Intra-operative, Cephalic, Muscular-skeletal, Trans-rectal, Trans-vaginal, Contrast Agent, Transesophageal and Peripheral-vascular
Indicated Patient Age Range
Not Found
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.
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
jan 2 4 2006
510(k) Premarket Notification
ACCUVIX V7Diagnostic 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:
December 15, 2005
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
ACCUVIX V7 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 XO Diagnostic Ultrasound System K013627, 11/16/2001, SA8000 Diagnostic Ultrasound System
4. Device Description:
The ACCUVIX V7 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.
1
The ACCUVIX V7 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 ACCUVIX V7 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 ACCUVIX V7 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
General, Obstetrics, Gynecology, Extremity, Urology, Breast. Renal, Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo, Carotid, Varicose, Fetal Abdominal, Small organ, Intra-operative, Cephalic, Muscular-skeletal, Trans-rectal, Trans-vaginal, Contrast Agent, Transesophageal and Peripheral-vascular applications.
6. Technological Characteristics:
The ACCUVIX V7 is substantially equivalent to the ACCUVIX 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
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K060087
Trade Name: ACCUVIX V7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 10, 2006 Received: January 12, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the ACCUVIX V7 Diagnostic Ultrasound System, as described in your premarket notification:
Image /page/2/Picture/11 description: The image is a circular seal with the letters "FDA" in the center. Above the letters, the numbers "1XX-XXX" are printed. Below the letters, the word "Centennial" is printed. The seal is surrounded by a dotted line and some text that is difficult to read.
Jing Public .
3
Transducer Model Number
| C1-4EC | MPT4-7AC |
|---|---|
| C2-6IC | P2-4AC |
| C3-7IM | P3-5AC |
| C5-2EL | P3-7AC |
| EC4-9ES | 3D2-5EH |
| EC4-9IS | 3D4-7EK |
| L4-7EL | 3D5-8EK |
| L6-12IS | VNW6-12 |
| L8-15IS | CW2.0 |
| LS5-13EC | CW4.0 |
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, Maryland 20850
4
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
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancyc Brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
| 510(k) No.: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device Name: | |||||||||
| ACCUVIX V7 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 | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| 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) | N | N | N | N | N | Note 1 | Note 8, 9 | ||
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Note 8, 9 | ||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2,4,5,6,7,8,9 | ||
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 | ||
| 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, 8 | ||
| Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 8 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 7, 8 | |||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2,5,6,8,9 | ||
| 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) | N | N | N | N | N | Note 1 | Note 7, 8 | ||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5, 6, 9 | |
| Other (spec.) | N |
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/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/ B/Color Doppler/Color M
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 K060082
6
510(k) No .:
| Device Name:
| C1-4EC for use with ACCUVIX V7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Intended Use: | ||||||||
| Clinical Application | ||||||||
| Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | 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 | ||||||||
| & 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 | ||||||||
| 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/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler,
B/Color Doppler/Color M
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 Beardon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number R060087
7
510(k) No.:
| 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 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler,
- B/Color Doppler/Color M
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 Brogdon | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K060087 |
8
510(k) No.:
| C3-7IM for use with ACCUVIX V7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | Ophthalmic | |||||||
| Fetal (See Note 3) | P | 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 | ||||||||
| & 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
ち:り火, Number
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
9
510(k) No.:
| C5-2EL for use with ACCUVIX V7
| Device Name: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Intended Use: | ||||||||
| 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 | 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 | ||||||||
| & 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler/PW Doppler,
B/Color Doppler/Color M
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 ________________________________________________________________________________________________________________________________________________________________
10
510(k) No .:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | ||||||||
| EC4-9ES for use with ACCUVIX V7 | ||||||||
| Intended Use: | ||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 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 by K013627 and K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler,
-
B/Color Doppler/Color M
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 brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K060087
510(k) Number
11
510(k) No.:
| Device Name: | EC4-9IS for use with ACCUVIX V7 | |||||||
|---|---|---|---|---|---|---|---|---|
| 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, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 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 by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler,
- B/Color Doppler/Color M
- 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. Burgdon
(Division Sign-Off)
Division of Reproductive and Radiological Devices 5 10(k) Number _______________________________________________________________________________________________________________________________________________________________
12
510(k) No.:
| Device Name: L4-7EL for use with ACCUVIX V7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 6, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | 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/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Bragdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060087
13
| 510(k) No.:
L6-12IS for use with ACCUVIX V7
| 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 | ||||||||
| (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) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Intra-operative (Neuro.) | |||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 9 | ||
| 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, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 5, 6, 9 |
| Other (spec.) |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
S ( "x) Number _______________________________________________________________________________________________________________________________________________________________
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
(Division Sign. Division of Reproductive, Abdomin ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
14
| 510(k) No.: | L8-15IS for use with ACCUVIX V7
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
(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 | P | P | P | | P | Note 1 | Note 2, 5, 6, 9 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 9 |
| | 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, 9 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 9 |
| | 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, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-modc
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, Abdominal,
and Radiological Devices
510(k) Number K060087
15
510(k) No.:
| 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) | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 8, 9 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | 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/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
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) |
(Division Sign Off)
Division of Reproductive, Abdominal,
an: @dintegical Devices
460082
5112J ; Number _______________________________________________________________________________________________________________________________________________________________
16
510(k) No .:
| MPT4-7AO for use with ACCUVIX V7
| Device Name: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Intended Use: | ||||||||
| Clinical Application | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | P | P | P | P | P | Note 1 | Note 7, 8 | |
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Note 7, 8 | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
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)
and Endiological Devices
: 1')(k) Number .
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
17
510(k) No .:
P2-4AC for use with ACCUVIX V7 Device Name: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation (includes simultaneous B-mode) Clinical Application Specific CWD Combined Other B M PWD Color General Doppler' (Spec.) (Spec.) (Track I only) (Tracks I & III) Ophthalmic Ophthalmic Fetal (See Note 3) P P Note 4, 7 Abdominal P P P Note 1 Intra-operative (See Note 6) Intra-operative (Neuro.) Laparoscopic Fetal Imaging Pediatric & Other . Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic P p P P P Note l 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 P Note 1 Note 4, 7 Cardiac Pediatric P P Note l Note 4, 7 Cardiac P P P Trans-esophageal (Cardiac) Other (spec.) Peripheral vessel Peripheral Vessel Other (spec.)
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
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 hogdon
(Division Sign-Of Division of Reproductive, Abdom and Padinlogical Devices 500kr Number _________________________________________________________________________________________________________________________________________________________________
18
510(k) No.:
| Device Name: P3-5AC for use with ACCUVIX V7
| 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 | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| 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 | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 10 |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 10 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Interaces Forrer (Tanpikado) Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler,
B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Bugdon
19
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| P3-7AC for use with ACCUVIX V7 | ||||||||
| 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 | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| 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 | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 10 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Includes Fower (Ampikado) Depler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Brogdon
(Division Sign-Off) 0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060087
20
510(k) No.:
| Device Name: 3D2-5EH for use with ACCUVIX V7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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) | 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 | ||||||||
| 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 by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Oolor Doppler Includes Forrer (Alapanasopler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-modc
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-Division of Reproductive, Abdom and Radiological Devices 51(Yk) Number --------------
21
510(k) No .:
| Device Name:
| 3D4-7EK for use with ACCUVIX V7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| 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 | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler,
B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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
22
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|----------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Trans-rectal | | P | P | P | | P | Note 1 | Notes 2, 8 |
| Trans-vaginal | | P | P | P | | P | 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
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
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
Nincy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
23
510(k) No .:
| Device Name: VNW6-12 for use with ACCUVIX V7 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | P | P | P | P | Note 1 | Note 2, 8 | |||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 8 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 8 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 8 | |||
| 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 2, 8 | ||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
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) | |
| (Division Sign-Off) |
. () Division of Reproductive, Abdominal, anc. Radiological Devices
5 : Tik) Number ______________________________________________________________________________________________________________________________________________________________
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
24
510(k) No.:
| 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 Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| 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.) | P |
N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| Radiological Devices | |
| K Number | K060087 |
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
25
| 510(k) No.: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CW4.0 for use with ACCUVIX V7 | |||||||||
| 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 | |||||||||
| (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 | 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 | |||||||||
| Vessel | Peripheral vessel | P | |||||||
| Other (spec.) | P |
N= new indication; P= previously cleared by K052911 and K013627; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler Includes I Ower (Ampinade) Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Nancy C. Swagdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K960087