Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
Device Facts
| Record ID | K171824 |
|---|---|
| Device Name | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Jul 18, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: - Abdominal - Gynecology (including endovaginal) - Obstetric - Cardiac - Small parts (Breast, Testes, Thyroid, etc.) - Urology - Musculoskeletal - Peripheral vascular - Intra-operative - Pediatric - Neonatal (including abdominal and cephalic) - Adult Cephalic
Device Story
Acclarix AX8 (portable laptop) and LX8 (cart-based) are diagnostic ultrasound systems sharing a common software platform (EUP). Systems use piezoelectric transducers to emit high-voltage bursts and detect reflected echoes to construct diagnostic images. Operated by physicians or allied health professionals in clinical settings. Features include B-mode, M-mode, Color, PDI/DPDI, PW, CW, and 3D/4D imaging. Output is displayed on an integrated screen for real-time visualization. Clinical utility includes fluid flow analysis and anatomical evaluation across various body regions. System includes automated measurement tools (e.g., Auto IMT, Auto Trace) and optimization features (e.g., One-Key-Optimization) to assist clinicians in diagnostic decision-making. Benefits include non-invasive diagnostic imaging and improved needle visualization for interventional procedures.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (IEC 60601-2-37, NEMA UD 3), and biocompatibility (ISO 10993).
Technological Characteristics
Piezoelectric transducer-based pulsed echo imaging. Systems support B, M, PW, CW, Color, PDI/DPDI, and 3D/4D modes. Connectivity includes wireless network support (FCC Part 15). Biocompatibility per ISO 10993. Software platform (EUP) supports automated measurements (Auto IMT, Auto Trace) and image optimization algorithms.
Indications for Use
Indicated for ultrasound evaluations in patients of all ages, including neonates, pediatric, and adults, for clinical applications including abdominal, gynecological (endovaginal), obstetric, cardiac, small parts (breast, testes, thyroid), urological, musculoskeletal, peripheral vascular, intra-operative, and cephalic imaging.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- Acclarix LX8 Diagnostic Ultrasound System (K162055)
Reference Devices
- Acclarix AX8 Diagnostic Ultrasound System (K161300)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC60 Diagnostic Ultrasound System (K152545)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd., M9 Diagnostic Ultrasound System (K152543)
Related Devices
- K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · May 24, 2018
- K202856 — Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 · Edan Instruments, Inc. · Jan 25, 2021
- K190186 — Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System · Edan Instruments, Inc. · Mar 28, 2019
- K162055 — Acclarix LX8 Diagnostic Ultrasound System · Edan Instruments, Inc. · Jan 31, 2017
- K063580 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 14, 2006
Submission Summary (Full Text)
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Public Health Service
Image /page/0/Picture/2 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 an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Edan Instruments Inc % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089
Re: K171824
Trade/Device Name: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, IYN Dated: June 12, 2017 Received: June 19, 2017
Dear Mr. Worth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
### 510(k) Number (if known)
K171824
#### Device Name
Acclarix AX8 Diagnostic Ultrasound System/Acclarix LX8 Diagnostic Ultrasound System
Indications for Use (Describe)
The Acclarix AX8 Diagnostic Ultrasound system Acclarix LX8 Diagnostic Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
- · Abdominal
- · Gynecology (including endovaginal)
- · Obstetric
- · Cardiac
- · Small parts (Breast, Testes, Thyroid, etc.)
- · Urology
- · Musculoskeletal
- · Peripheral vascular
- · Intra-operative
- · Pediatric
- · Neonatal (including abdominal and cephalic)
- · Adult Cephalic
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### Acclarix AX8 Diagnostic Ultrasound System
| | Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|------------------------------|--|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3][4] | |
| | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | P | P | P | P | |
| | Intra-operative (Specify) | P | P | P | | P | P | P | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | |
| | Small Organ (Specify) * | P | P | P | | P | P | P | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | N | N | N | | N | N | N | |
| | Adult Cephalic | N | N | N | N | N | N | N | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | |
| | Intravascular | | | | | | | | |
| | Other (Specify) ** | P | P | P | | P | P | P | |
| | Adult Cardiac | P | P | P | P | P | P | P | |
| | Pediatric Cardiac | P | P | P | P | P | P | P | |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P | |
| | Other (Specify) | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology |
|--------------------------------------------------------------------------|
| [1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging |
| [2]: Biopsy Guidance |
| [3]: Harmonic Imaging, This feature does not use contrast agent. |
| [4]: 3D/4D |
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Concurrence of Center for Devices and Radiological Health (CDRH)
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### Acclarix AX8 with C5-2Q Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | P | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | |
| Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | N | N | N | N |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | P | P | P | P |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology |
|--------------------------------------------------------------------------|
| [1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging |
| [2]: Biopsy Guidance |
| [3]: Harmonic Imaging. This feature does not use contrast agent |
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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### Acclarix AX8 with L12-5Q Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic<br>Fetal<br>Imaging | | | | | | | | |
| | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | P | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| & Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | P | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | P | P | P | P |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | P | P | P | P |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
* Small Organ includes Thyroid, Testes, Breast. Note
** Other use includes Urology.
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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### Acclarix AX8 with MC8-4Q Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N |
| | Small Organ (Specify) * | | | | | | | |
| Fetal | Neonatal Cephalic | N | N | N | | N | N | N |
| Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | N | N | N | | N | N | N |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
* Small Organ includes Thyroid, Testes, Breast. Note
** Other use includes Neonatal abdominal.
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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#### Acclarix AX8 with L10-4Q Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| | | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| General | Specific | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast.
** Other use includes Urology, Gynecology.
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{8}------------------------------------------------
#### Acclarix AX8 with E8-4Q Transducer
| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal | Neonatal Cephalic | | | | | | | |
| Imaging | Adult Cephalic | | | | | | | |
| & Other | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW
______________________________________________________________________________________________________________________________________________________________________________
Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{9}------------------------------------------------
#### Acclarix AX8 with L17-7HQ Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{10}------------------------------------------------
### Acclarix AX8 with C5-2XQ Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | P | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | N | N | N | N | N | N | N |
| | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | P | P | P | P |
| | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
| ** Other use includes Urology, Gynecology |
|--------------------------------------------------------------------------|
| [1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging |
| [2]: Biopsy Guidance |
| [3]: Harmonic Imaging This feature does not use contrast agent |
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{11}------------------------------------------------
### Acclarix AX8 with P5-1XQ Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| Fetal<br>Imaging | Neonatal Cephalic | | | | | | | |
| & Other | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | P | P | P | P | P | P | P |
| | Pediatric Cardiac | P | P | P | P | P | P | P |
| Cardiac | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M,B+CW,B+Color, B+PDI/DPDI, B+Color+PW, B+PD/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{12}------------------------------------------------
#### Acclarix AX8 with L17-7SQ Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|---------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | P | P | | P | P | P |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| | Peripheral<br>vascular | Peripheral vascular | N | N | N | | N | N |
| | | Other (Specify) | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
* Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
{13}------------------------------------------------
### Acclarix AX8 with C5-2MQ Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | | Mode of Operation | | | | | | |
|--|-----------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|---------------------------|
| | General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3][4] |
| | Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal Imaging & Other | Fetal / Obstetrics | N | N | N | N | N | N | N |
| | | Abdominal | | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Specify) * | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Musculo-skeletal(Conventional) | | | | | | | |
| | | Musculo-skeletal (Superficial) | | | | | | | |
| | | Intravascular | | | | | | | |
| | | Other (Specify) ** | | | | | | | |
| | Cardiac | Adult Cardiac | | | | | | | |
| | | Pediatric Cardiac | | | | | | | |
| | | Intravascular(Cardiac) | | | | | | | |
| | | Trans-esoph.(Cardiac) | | | | | | | |
| | | Intra- cardiac | | | | | | | |
| | Peripheral vascular | Peripheral vascular | | | | | | | |
| | | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging. This feature does not use contrast agent.
[4]: 3D/4D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{14}------------------------------------------------
### Acclarix LX8 Diagnostic Ultrasound System
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|------------------------|--------------------------|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify)[2][3][4] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | P | P | P | P | P | P | P |
| | Intra-operative (Specify) | P | P | P | | P | P | P |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | P | P | P | | P | P | P |
| Cardiac | Adult Cardiac | P | P | P | P | P | P | P |
| | Pediatric Cardiac | P | P | P | P | P | P | P |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDVDPDI, B+Color+PW, B+PDI/DPDI +PW, B+CW, B+Color+CW, B+PDI/DPDI+CW,
Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology and Neonatal adbdominal
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance .
[3]: Harmonic Imaging, This feature does not use contrast agent.
[4]: 3D/4D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
{15}------------------------------------------------
### Acclarix LX8 with L10-4D Transducer
| | Clinical Application | Mode of Operation | | | | | | | |
|------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|--|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | P | P | P | |
| Fetal<br>Imaging | Neonatal Cephalic | | | | | | | | |
| & Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | |
| | Intravascular | | | | | | | | |
| | Other (Specify) ** | | | | | | | | |
| | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | | | | | | | | |
| Cardiac | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P | |
| vascular | Other (Specify) | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast.
** Other use includes Urology, Gynecology.
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
- [2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{16}------------------------------------------------
### Acclarix LX8 with E8-4D Transducer
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix PDI=Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
- [2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
{17}------------------------------------------------
### Acclarix LX8 with L17-7HD Transducer
| | Clinical Application | Mode of Operation | | | | | | |…
