ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K093849 |
|---|---|
| Device Name | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 19, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, intraoperative and etc.
Device Story
ACCUVIX V10 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in 2D, M-mode, Color Doppler, Power Doppler, PW/CW Spectral Doppler, and Tissue Doppler modes. It also supports 3D/4D imaging using mechanical scan probes. The system is operated by healthcare professionals in clinical settings. It provides real-time acoustic output (mechanical and thermal indices) and includes measurement/analysis packages for anatomical structures and fluid flow. Output is displayed on an LCD for clinical diagnostic decision-making. The device benefits patients by providing non-invasive diagnostic imaging and guidance for procedures like biopsies.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 60601-1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1 for biocompatibility.
Technological Characteristics
Mobile diagnostic ultrasound system. Materials comply with ISO 10993-1. Sensing via piezoelectric transducers. Energy source: electrical/ultrasonic. Connectivity: standard ultrasound interface. Software-controlled. Safety standards: UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in general, abdominal, obstetric, gynecologic, vascular, extremity, pediatric, cardiac, breast, urologic, neonatal cephalic, and trans-esophageal applications. Prescription use only.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ACCUVIX V10 Diagnostic Ultrasound System (K070813)
- ACCUVIX V20 Diagnostic Ultrasound System (K092159)
Related Devices
- K070813 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Apr 10, 2007
- K080800 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Apr 7, 2008
- K092159 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jul 28, 2009
- K112339 — ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Aug 29, 2011
- K052911 — ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Oct 31, 2005
Submission Summary (Full Text)
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K093849
510(k) Premarket Notification
# JAN 1 9 2010
ACCUVIX V10 Diagnostic Uitrasound 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. 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: September 7, 2009
#### 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 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
#### 3. Identification of the predicate or legally marketed device:
K070813, ACCUVIX V10 Diagnostic Ultrasound System K092159, ACCUVIX V20 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 mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode.
The ACCUVIX V10 has real time acoustic output display with two basic indices, a
ATTACHMENT 1(b)
{1}------------------------------------------------
510(k) Premarket Notification
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
- 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:
General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, intraoperative and etc.
#### 6. Technological Characteristics:
The ACCUVIX V10 is substantially equivalent to the ACCUVIX V10 Diagnostic Ultrasound System, cleared via K070813, and the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
#### END of 510(K) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
# JAN 1 9 2010
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K093849
Trade/Device Name: ACCUVIX V10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 7, 2010 Received: January 8, 2010
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 V10 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | | |
|-------------------------|------------|------------|
| 3D2-6ET | C2-61C | NER4-9ES |
| 3D4-8ET | C3-71M | NEV4-9ES |
| 3D4-9ES | C4-9/10ED | L4-7EL |
| 3D5-9EK | EC4-9IS | L5-12/50EP |
| V6-12 | ER4-9/10ED | L5-13IS |
| C2-5EL | EV4-9/10ED | L6-12IS |
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| L7-16IS | MPT4-7 | P3-8CA |
|---------|--------|--------|
| L8-15IS | P2-4AC | CW 2.0 |
| LS5-13 | P2-4BA | CW 4.0 |
| LT4-7 | P3-5AC | |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Andrew Kang at (301) 796-6544.
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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… ﺃﺭ
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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
| | Clinical Application | | | | | | Mode of Operation (*includes simultaneous B-mode) | |
|---------------------------|---------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal ( <i>See Note 3</i> ) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | P | | | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | 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 Adult | | | | P | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared under K070813; 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) (*OIVD*)
Prescription Use (Per 21 CFR 801.109)510(k) Number K093849
"
1. 1.
・
:
.
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---
#### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
| 510(k) No.: | K093849 |
|---------------|------------------------------------------------------------------------------------|
| 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 | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | P | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared under K070813; E= added under Appendix E
#### 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, 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
signature
Concurrence of CDRH, Callion and Prescription Use (Per 21 CFR 801.109)
510(k) Number: K093849
{6}------------------------------------------------
| 510(k) No.: | |
|--------------|---|
| Device Name: | 1 |
# Ko 93849 P3-8CA 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BM, 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
S.L.R.
Concurrence of CDRH, Oblisa of Dougles Forman Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{7}------------------------------------------------
| 510(k) No.: | K093849 | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | |
| & Other | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | 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 | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared under K070813; 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
signature
.
Concurrence of CDRH, @ffee of Davises Excalin Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Devices
510(k) Number_15093849
{8}------------------------------------------------
| 510(k) No.: | K093849 |
|---------------|------------------------------------------------------------------------------------|
| Device Name: | P2-4BA 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | | | |
| | Intra-operative (See Note 6) | | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | | |
| Fetal Imaging<br>& 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<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |
N= new indication; P= previously cleared under K092159; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BM, B/PWD, B/CWD, B/Color Doppler, B/PWD/Color Doppier/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
signature
Concurrence of CDRH, @ffice of Bevice Evaluation Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{9}------------------------------------------------
| 510(k) No.: | K093849 | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| Device Name: | P2-4AC 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
new indication; P= previously cleared under K070813; 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 (OBB) Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{10}------------------------------------------------
| 510(k) No.: | K093849 |
|---------------|------------------------------------------------------------------------------------|
| Device Name: | MPT4-7 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& 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<br>Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | P | P | P | | P | Note 1 | Note 7, 8 |
| | Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Intra-luminal<br>Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | N | N | N | | N | Note 1 | Note 7, 8 |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared under K092159; 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, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
DNR
---
#### Concurrence of CDRH, Office of Berice Brahaution Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{11}------------------------------------------------
| 510(k) No.: | K093849 |
|---------------|------------------------------------------------------------------------------------|
| Device Name: | LT4-7 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| | Ophthalmic | Ophthalmic | | | | | | | |
| | | Fetal (See Note 3) | | | | | | | |
| | | Abdominal | | | | | | | |
| | | Intra-operative (See Note 6) | N | N | N | | N | Note I | Note 8, 9 |
| | | Intra-operative (Neuro.) | N | N | N | | N | Note I | Note 8, 9 |
| Fetal Imaging<br>& 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<br>Vessel | | Peripheral vessel | | | | | | | |
| | | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
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 3. Includes inventory monitoring of router.
Note 4. Color M mode.
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 (OBE) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
510(k) Number K093849
{12}------------------------------------------------
Ko 83847 510(k) No .: Device Name:
LS5-13 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) Specific B General 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) P P P P Note 8, 9 Note l Intra-operative (Neuro.) P P P P Note 8, 9 Note l Fetal Imaging Laparoscopic & Other Pediatric P P P p Note 8, 9 Note I Small Organ (See Note 5) P P P P Note 1 Note 8, 9 Neonatal Cephalic P P P P Note l Note 8, 9 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent ) P P P P Note l Note 8, 9 Musculo-skel. (Superfic.) P P P P Note l Note 8, 9 Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel P P P P Note I Note 5, 6, 9 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: BM, 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, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
D.L.P.
Concurrence of CDRH, Office of Bevice Evaluatia Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{13}------------------------------------------------
# Ko93849
510(k) No .: Device Name:
L8-15IS for use with ACCUVIX V10 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | P | Note 1 | Note 2, 5, 6, 9 |
| | Small Organ (See Note 5) | P | 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 | P | Note 1 | Note 2, 5, 6, 9 |
| | Musculo-skel. (Superfic.) | P | 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 | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 9 |
| Vessel | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared under K070813; 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, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
signature
## Concurrence of CDRH, Gifter a Clouico Frielacati Prescription Use (Per 21 CFR 801.109)
510(k) Number K093849
{14}------------------------------------------------
| 510(k) No.: | K093849 | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| Device Name: | L7-16IS 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& 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 | | | | | | | |
| | Tr…
