(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, ML, or related concepts in the provided text. The description of image processing is typical for ultrasound devices and does not indicate AI/ML.
No.
The device is explicitly described for "diagnostic ultrasound imaging and fluid analysis of the human body," and its function is to "acquire ultrasound data and to display the data" for "clinical diagnostic purposes," not for treatment.
Yes
The intended use explicitly states, "The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Also, the device description mentions that the system "provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "general purpose, mobile, software controlled, diagnostic ultrasound system" and mentions acquiring ultrasound data and displaying it. This implies the presence of hardware components (transducers, display, etc.) necessary for ultrasound imaging, even though the system is software-controlled.
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 the body directly, not a device that analyzes samples taken from the body (which is the core function of an IVD).
- Device Description: The description focuses on acquiring and displaying ultrasound data from within the body. It mentions "measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes," but this is based on the ultrasound imaging, not on analyzing biological samples.
- Input Imaging Modality: The input is Ultrasound, which is an imaging technique applied to the body, not a method for analyzing samples.
- Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound imaging is performed.
- No mention of analyzing biological samples: There is no indication that this device interacts with or analyzes blood, urine, tissue, or any other biological sample.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by sending and receiving ultrasound waves to create images of internal structures, which is a different diagnostic approach.
N/A
Intended Use / Indications for Use
The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.
AC CV IX V10 Diagnostic Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application:
- Fetal
- 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)
- Musculo-skel. (Convent.)
- Musculo-skel. (Superfic.)
- Intra-luminal
- Other (spec.)
- Cardiac Adult
- Cardiac Pediatric
- Trans-esophageal (Cardiac)
- Other (spec.)
- Peripheral vessel
- Other (spec.)
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
The ACCUVIX V10 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 LCD display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode.
The ACCUVIX V10 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdomen, OB, Gynecology, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Head (TCD), Urology, Cardiac, Fetal, Intra-operative, Pediatric, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-Cardiac), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intra-luminal, Peripheral vessel
Indicated Patient Age Range
Adult, Pediatric, Neonatal (for small organs)
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
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K070813". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The contrast between the characters and the background is high, making them easily readable.
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: March 15, 2007
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
ACCUVIX V10 Diagnostic Ultrasound System
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3. Identification of the predicate or legally marketed device:
K052911, 10/31/2005, ACCUVIX XQ Diagnostic Ultrasound System K063580, 12/14/2006, SONOACE X8 Diagnostic Ultrasound System
4. Device Description:
The ACCUVIX V10 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 LCD display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode.
The ACCUVIX V10 has real time acoustic output display with two basic indices, a
510(k) Summary of Safety and Effectiveness
ATTACHMENT 1(b)
APR 1 0 2007
1
mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
The ACCUVIX V10 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, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1. Biocompatibility
5. Intended Uses:
The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:
Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.
6. Technological Characteristics:
The ACCUVIX V10 is substantially equivalent to the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911, 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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medison Co., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
APR 1 0 2007
Re: K070813
Trade Name: ACCUVIX V10 Diagnostic Ultrasound System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO and ITX Dated: March 23, 2007 Received: March 26, 2007
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 ACCUVIX V10 Diagnostic Ultrasound System, as described in your premarket use with the notification:
Transducer Model Number
| 3D2-5EH | 3D2-5EL | 3D2-6ET | 3D4-8ET | 3D4-9ES | C1-4EC |
|---|---|---|---|---|---|
| C2-5EL | C2-6IC | C3-7IM | C4-9/10ED | EC4-9IS | NER4-9ES |
| NEV4-9ES | L4-7EH | L5-12/50EP | L5-12ID | L6-12IS | L8-15IS |
| P2-4AC | P3-5AC | P3-7AC | CW 2.0 | CW 4.0 |
3
Page 2 - Mr. Mark Job
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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
If you have any questions regarding the content of this letter, please contact John Chen, Ph.D., at (240) 276-3666.
Sincerely yours,
David R. Ingram
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No .: Device Name:
ACCUVIX V10 Diagnostic Ultrasound System 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 | 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, 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 2,5,6,8,9 | |
| 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) | ||||||||
| 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/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| Prescription Use (Per 21 CFR 801.109) |
David h. Gyson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
5
510(k) No .:
Device Name: 3D2-5EH for use with ACCUVIX V10
| 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 | P | Note 1 | Notes 2, 7, 8 | |
| Abdominal | P | 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 | 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 | 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/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler:M, B/Color Doppler/M, B/Color Doppler/CWD Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, 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
David A. Ingram
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
6
510(k) No .:
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Laparoscopic | |||||||||||
| & Other | 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 | Peripheral vessel | |||||||||||
| Vessel | Other (spec.) |
580; E= added under Appendix E new indication: P= previously cleared
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, 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
Daniel R. Szymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
7
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | 3D2-6ET for use with ACCUVIX V10 | |||||||
| 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 | ||||||||
| 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 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/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David A. Hyman
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
8
510(k) No.:
Device Name: 3D4-8ET for use with ACCUVIX V10
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 (Tracks I & III) (Track I only) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) P p P P Note 1 Notes 2, 7, 8 Abdominal Note 1 Notes 2, 7, 8 P P P P Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic Pediatric & Other Notes 2, 7, 8 P P P P Note l Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)
N= new indication; P= previously cleared under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David A. Sayre
(Division Sian-Off) ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
9
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | 3D4-9ES for use with ACCUVIX V10 | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |||||||
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
| 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 | Notes 2, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 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 | 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/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, 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)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
10
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | C1-4EC for use with ACCUVIX V10 | |||||||
| 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) | 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 | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K060087; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Daniel A. Rogers
(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number
11
| 510(k) No.:
| Device Name: | C2-5EL for use with ACCUVIX V10 | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Daniel A. Hagerman
(Division Sign-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number
12
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | C2-6IC for use with ACCUVIX V10 | |||||||
| 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 | ||||||||
| 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
K052911; E= added under Appendix E pi
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BM, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David A. Symon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
13
510(k) No .:
| Device Name: | C3-7IM for use with ACCUVIX V10 |
|---|---|
| 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) | 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 under K032329 and K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
14
510(k) No .:
| Device Name: | C4-9/10ED for use with ACCUVIX V10 | |||||||
|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | ||||||||
| 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 | Note 2, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Note 2, 8 | ||
| 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 | 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 | Cardiac Adult | |||||||
| 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 under K43455 and K053530; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Preseription Use (Per 21 CFR 801.109)
Elvin le Segnern
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
15
510(k) No .:
| Device Name: | EC4-9IS for use with ACCUVIX V10 | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 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, 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K032329 and K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Edward A. Ingram
ision Sign-Off) sion of Reproductive, Abdominal, and Radiological Devices 510(k) Number
16
| 510(k) No.: | |
|---|---|
| Device Name: | NER4-9ES for use with ACCUVIX V10 |
| 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 | ||||||||
| 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 under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10
Daniel K. Inouye
(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Numbe
17
510(k) No .:
NEV4-9ES for use with ACCUVIX V10 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 PWD CWD Combined Other Specific B M Color General (Tracks I & III) Doppler* (Spec.) (Spec.) (Track I only) 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 under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler:M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David Lennon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
18
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | L4-7EH for use with ACCUVIX V10 | |||||||
| 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.) | ||||||||
| 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 | Cardiac Adult | |||||||
| 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 under K063580; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David de Segarra
19
510(k) No .:
Device Name: L5-12/50EP for use with ACCUVIX V10 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 2, 5, 6, 7, 9 Note l Small Organ (See Note 5) P P P P Note 1 Note 2, 5, 6, 7, 9 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) P Note 2, 5, 6, 7, 9 p P P Note 1 Musculo-skel. (Superfic.) P P P Note 2, 5, 6, 7, 9 P Note l Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Note 2, 5, 6, 7, 9 P P P P Note 1 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/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David Le Segura
(Division Sign-Off) vision of Reproductive, Abdominal, and Radiological Devices 510(k) Number
20
510(k) No .:
| Device Name: | L5-12ID for use with ACCUVIX V10 |
|---|---|
| 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 | Laparoscopic | |||||||
| & Other | Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 |
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Prescription Use (Per 21 CFR 801.1
Daniel G. Benner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
21
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | L6-12IS for use with ACCUVIX V10 | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Mode of Operation (*includes simultaneous B-mode) | ||||||||
| Clinical Application | ||||||||
| 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, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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, 7, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared under K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Daniel br. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
22
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | L8-15IS for use with ACCUVIX V10 | |||||||
| 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 | ||||||||
| 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 | Note 1 | Note 2, 5, 6, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared under K052911; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) · Prescription Use (Per 21 CFR 801.109)
Florind A. Simpson
(Division Sign-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number
23
510(k) No .:
P2-4AC for use with ACCUVIX V10 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 Imaging | ||||||||
| & Other | Fetal ( See Note 3 ) | |||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative ( See Note 6 ) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| 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 |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared under K052911 and K060087; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Daniel A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
24
510(k) No .:
| Device Name: | P3-5AC for use with ACCUVIX V10 |
|---|---|
| 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 Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K06008; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler/M, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Daniel R. Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
25
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Device Name: | P3-7AC for use with ACCUVIX V10 | |||||||
| 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 Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by K052911 and K06008; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David h. Simpson
(Division Sign-Off) (Division Orgin Orgin of Reproductive, Abdominal, and Radiological Devices 510(k) Number
26
510(k) No .:
| Device Name: | CW 2.0 for use with ACCUVIX V10 | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 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.) |
N= new indication; P= previously cleared K052911 and K06008; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
David A. Logemann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
27
| 510(k) No.: | |
|---|---|
| Device Name: | CW 4.0 for use with ACCUVIX V10 |
| 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 Imaging & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | P | |||||||
| 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 by K052911 and K06008; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/M, B/Color Doppler/CWD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
どで
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Daniel R. Larson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number