ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K112339 |
|---|---|
| Device Name | ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Samsung Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Aug 29, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ACCUVIX A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Device Story
ACCUVIX A30 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays images in B-mode, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Operated by healthcare professionals in clinical settings, the device allows for anatomical measurements and analysis packages to support diagnosis. It provides real-time acoustic output display (mechanical and thermal indices). The system processes received echoes to generate on-screen anatomical and fluid flow visualizations. Clinicians use these outputs to guide clinical decision-making, such as biopsy guidance or monitoring follicle development. Benefits include non-invasive diagnostic imaging and fluid flow assessment.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO 10993-1 for biocompatibility.
Technological Characteristics
Mobile diagnostic ultrasound system. Modes: B, M, Color/Power Doppler, PW/CW Doppler, Harmonic, Tissue Doppler, 3D/4D, Elastoscan. Biocompatibility per ISO 10993-1. Safety compliance: UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, NEMA UD-2/UD-3. Software-controlled. Transducers: C1-4, C2-6IC, C5-8, EC4-9IS, L4-7, L5-13IS, L7-16IS, P2-4BA, V2-6, V5-9, CW2.0, CW4.0, CW6.0.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Used by clinicians for anatomical measurement and diagnosis.
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 XG Diagnostic Ultrasound System (K103397)
- ACCUVIX V20 Diagnostic Ultrasound System (K092159)
Related Devices
- K080800 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Apr 7, 2008
- K052911 — ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Oct 31, 2005
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
- K093849 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 19, 2010
- K103397 — ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Feb 25, 2011
Submission Summary (Full Text)
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#### AUG 2 9 2011 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)
SAMSUNG MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
### Contact Person:
Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|------------|----------------|
| Facsimile: | 82.2.556.9209 |
Data Prepared: June 24, 2011
## 2. Name of the device:
| Common/Usual Name: | | |
|----------------------------------------------|-----------|--------------|
| Diagnostic Ultrasound System and Accessories | | |
| Proprietary Name: | | |
| ACCUVIX A30 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:
- ACCUVIX XG Diagnostic Ultrasound System (K103397) -
- -ACCUVIX V20 Diagnostic Ultrasound System (K092159)
{1}------------------------------------------------
## 4. Device Description:
The ACCUVIX A30 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The ACCUVIX A30 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX A30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The ACCUVIX A30 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
- TEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
### 5. Intended Uses:
The ACCUVIX A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
## 6. Technological Characteristics:
The ACCUVIX A30 is substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX XG Diagnostic Ultrasound System (K103397) and ACCUVIX V20 Diagnostic Ultrasound System (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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SAMSUNG Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
AUG 2 9 2011
Re: K112339
Trade/Device Name: ACCUVIX A30 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: August 12, 2011 Received: August 15, 2011
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 A30 Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
| C1-4 | L5-13IS | CW-2.0 |
|---------|---------|--------|
| C2-61C | L7-16IS | CW4-0- |
| C5-8 | P2-4BA | CW6-0- |
| EC4-9IS | V2-6 | |
| L4-7 | V5-9 | |
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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 895. 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 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 Lauren Hefner at (301) 796-6881.
Sincerely Yours.
Michael D'Amico
Mary S. Pastel, Sc.D. 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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ACCUVIX A30 Diagnostic Ultrasound System
Image /page/4/Picture/1 description: The image shows a document with the text "510(k) Premarket Notification" at the top. Below this, the text "FDA CDRH DMC" is written in a circular fashion. Further down, the date "AUG 15 2011" is visible, also oriented in a circular manner.
## SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ACCUVIX A30 Diagnostic Ultrasound System
Indications for Use:
The ACCUVIX A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mh D. O'h
Division of Radiological Devic Office of In
Indications for Use
filed 510(k) In Vitro Diagnostic Device Data
510K. K112339
{5}------------------------------------------------
510(k) No.:
Device Name: ACCUVIX A30 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|---------------------------|
| General<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) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Abdominal | N | N | N | N | N | Note 1 | Notes 2, 4, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 10 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 2, 7, 8 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 7, 8, 10 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 7, 8, 10 |
| | 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 | 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<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Amal D. O'Hare
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K112339
510K
{6}------------------------------------------------
510(k) No.:
Device Name: C1-4 for use with ACCUVIX A30 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) | 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<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac 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
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Indications for Use
Division Sion-Of Division of Radiological Devices Office of In Device Evaluation and Safety
510K K112339
{7}------------------------------------------------
510(k) No.:
## Device Name: C2-6IC for use with ACCUVIX A30 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 Imaging<br>& Other | 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.) | | | | | | | |
| | 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. (Supertic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K103397; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Office of In Diagnostic Device Evaluation and Safety
510K KJ12339
Section 1.3, page 4
{8}------------------------------------------------
## 510(k) No.: Device Name: C5-8 for use with ACCUVIX A30 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) | 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<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2, 7, 8 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Michael D. O'Shea
Indications for Use
Division of Radiolo Office of In tion and Safety
Section 1.3, page 5
{9}------------------------------------------------
### 510(k) No.: Device Name: EC4-9IS for use with ACCUVIX A30 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 1 & 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 | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 10 |
| | Trans-vaginal | P | P | P | | P | Note I | Note 2, 7, 8, 10 |
| | 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 by FDA K092159; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112239
{10}------------------------------------------------
## 510(k) No.: Device Name: L4-7 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
|---------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | 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<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Notel 0: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
hnd D. O'K
Indications for Use
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{11}------------------------------------------------
### 510(k) No.: Device Name: L5-13IS for use with ACCUVIX A30 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, 7, 9 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10 |
| | 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<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K103397; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Director)
on of Radiologic
510K K112339
Section 1.3, page 8
{12}------------------------------------------------
### 510(k) No.: Device Name: L7-16IS for use with ACCUVIX A30 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, 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<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+C, Dual B+PD
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 Hannonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
***(Division Sign-Off)***
Division of Radiological Devices Evaluation and Safety
K112339
510K
{13}------------------------------------------------
510(k) No.:
# Device Name: P2-4BA for use with ACCUVIX A30 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 | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K103397; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
A.A.D.O'h
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112339
Section 1.3, page 10
{14}------------------------------------------------
### 510(k) No.: Device Name: V2-6 for use with ACCUVIX A30 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) | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | Abdominal | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Note 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B, Dual B+C, Dual B+PD
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note S: 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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Michael D. O'Brien
Indications for Use
(Division Sign-Off Division of Radiological Devices Evaluation and Safety
61123339
{15}------------------------------------------------
#### 510(k) No.:
## Device Name: V5-9 for use with ACCUVIX A30
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 1 & 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 | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K103397; E= added under Appendix E
#### Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B+C, Dual B+PD
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
Note10: ElastoScan
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
*(Division Sign-Off)*
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112339
{16}------------------------------------------------
### 510(k) No.: Device Name: CW2.0 for use with ACCUVIX A30 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
tion (Kingludge vinnellan
| 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 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 |…
