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
Device Facts
| Record ID | K202856 |
|---|---|
| Device Name | 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 |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 25, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include: Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intraoperative, Pediatric, Neonatal, Adult Cephalic.
Device Story
Diagnostic ultrasound system (Acclarix AX3/LX3 series) for clinical imaging; acquires and displays ultrasound data via various transducers. Operates in B-mode, M-mode, Doppler, Harmonic Imaging, Anatomic M, TDI, and 3D/4D modes. Used by physicians or allied health professionals in hospitals/clinics. System processes acoustic signals to generate real-time images for diagnostic evaluation. Includes automated measurement functions like Auto IMT and Auto EF. Output displayed on system monitor for clinical decision-making; aids in diagnosis and biopsy guidance. Benefits include non-invasive visualization of internal structures and blood flow.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (ANSI/AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasonic safety (IEC 60601-2-37), and biocompatibility (ISO 10993-1, -5, -10).
Technological Characteristics
Software-controlled diagnostic ultrasound system. Transducers utilize piezoelectric materials. Connectivity includes standard ultrasound interfaces. Biocompatibility per ISO 10993. Imaging modes: B, M, Doppler, Harmonic, Anatomic M, TDI, 3D/4D. Includes needle guide brackets.
Indications for Use
Indicated for ultrasound evaluations in hospitals and clinics for patients requiring abdominal, gynecological, obstetric, cardiac, small parts, urological, musculoskeletal, peripheral vascular, intraoperative, pediatric, neonatal, and adult cephalic imaging.
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
- Edan Instruments, Acclarix AX3 series Diagnostic Ultrasound System (K192791)
Reference Devices
- Edan Instruments, Acclarix LX9 series Diagnostic Ultrasound System (K192879)
- George J. Hattub, LVivo Software Application (K200232)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd, DC-90 Diagnostic Ultrasound System (K201693)
Related Devices
- K190186 — Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System · Edan Instruments, Inc. · Mar 28, 2019
- K072676 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Dec 18, 2007
- K192152 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 13, 2019
- K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 19, 2009
- K180039 — ACUSON P600 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration. The logo consists of a blue square on the left side, followed by the text "ADMINISTRATION" in blue. The text is in a sans-serif font and is aligned to the right of the blue square.
January 25, 2021
Edan Instruments, Inc. % Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, Guangdong 518122 P R CHINA
# Re: K202856
Trade/Device Name: 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 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 25, 2020 Received: December 28, 2020
Dear Ying Dai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K202856
## Device Name
Diagnostic Ultrasound System; Models: Acclarix AX3 Exp. Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX18; Acclarix LX3, Acclarix LX3, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28
## Indications for Use (Describe)
The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gvnecology, Obstetric. Cardiac, Small parts. Urology, Musculosketal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.
The modes of operation for Acclarix AX3 series include B mode, M mode, M mode, Doppler mode, Harmonic Imaging, and their combination modes.
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 AX3 Series/Acclarix LX3 Series Diagnostic Ultrasound System
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<br>(Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] [4] |
| | Abdominal**** | P | P | P | P | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | N | N | N | N | N | Note[1] | Note[2] [3] |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note[1] | Note[2] [3] |
| | Small Organ (Specify) ** | P | P | P | | P | Note[1] | Note[2] [3] |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | N | N | N | N | N | Note[1] | Note[2] [3] |
| | Adult Cephalic | P | P | P | P | P | Note[1] | Note[2] [3] |
| | Trans-rectal | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-vaginal | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| Cardiac | Adult Cardiac | P | P | P | P | P | Note[1] | Note[2] [3] [5] [6] |
| | Pediatric Cardiac | N | N | N | N | N | Note[1] | Note[2] [3] [5] [6] |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | Note[1] | Note[2] [3] |
| vascular | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ Thyroid, Testes, Breast. ***Other use includes Urology Gynecology. ****Abdominal includes ABD and lung scanning.
| [1]: Combined mode: B+M, B+PW, B+Color,<br>B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy<br>Guidance | [3]: Harmonic Imaging. This<br>feature does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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## C5-2Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|---------------|---------------------------------|-------------------|---|----|----|--------|-----------|-------------|
| General | Specific | B | M | PW | CW | Color* | Combined | Other |
| | | | | | | | (Specify) | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] |
| | Abdominal **** | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging | Neonatal Cephalic | | | | | | | |
| & Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
****Abdominal includes ABD and lung scanning.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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### C7-2XQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------|---------------------------------|-------------------|---|----|----|--------|--------------------|-----------------|
| General | Specific | B | M | PW | CW | Color* | Combined (Specify) | Other (Specify) |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] |
| | Abdominal **** | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging & Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral vascular | 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
****Abdominal includes ABD and lung scanning.
| [1]: Combined mode: B+M, B+PW, B+Color,<br>B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy<br>Guidance | [3]: Harmonic Imaging.This feature<br>does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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### C5-1Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|---------------------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color*<br>(Specify) | Combined<br>(Specify) | Other<br>(Specify) |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] |
| | Abdominal **** | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| | 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
| ****Abdominal includes ABD and lung scanning. | | |
|-----------------------------------------------|--|--|
| | | |
| | | |
| [1]: Combined mode: B+M, B+PW, B+Color,<br>B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy<br>Guidance | [3]: Harmonic Imaging. This feature<br>does not use contrast agent. | [4]: 3D/4D |
|-----------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic<br>M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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## C6-2MQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | |
|--------------------------|---------------------------------|------------|-------------------|----|----|---------------------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color*<br>(Specify) | Combined<br>(Specify) | Other<br>(Specify) |
| | | Ophthalmic | Ophthalmic | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] [4] |
| | Abdominal | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| | Adult Cardiac | | | | | | | |
| 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 Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
***Other use includes Gynecology. ** Small Organ includes Thyroid, Testes, Breast.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
### L12-5Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|--------|-----------------------|--------------------|
| | Specific | B | M | PW | CW | Color* | Combined<br>(Specify) | Other<br>(Specify) |
| General | Specific | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal **** | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | P | P | P | | P | Note[1] | Note[2] [3] |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | Note[1] | Note[2] [3] |
| 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
****Abdominal includes lung scanning.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
## L17-7HQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|--------|-----------------------|--------------------|--|
| General | Specific | B | M | PW | CW | Color* | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) ** | P | P | P | | P | Note[1] | Note[2] [3] | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Intravascular | | | | | | | | |
| | Other (Specify) *** | | | | | | | | |
| | Adult Cardiac | | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | Note[1] | Note[2] [3] | |
| | 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.This<br>feature does not use contrast<br>agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
## L17-7SQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|---------------|---------------------------------|-------------------|---|----|----|--------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color* | Combined<br>(Specify) | Other<br>(Specify) |
| | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging | Neonatal Cephalic | | | | | | | |
| & Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | Note[1] | Note[2] [3] |
| 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
Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
| ** Small Organ includes Thyroid, Testes, Breast. | ***Other use includes Urology and Gynecology. |
|--------------------------------------------------|-----------------------------------------------|
|--------------------------------------------------|-----------------------------------------------|
| [1]: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging. This feature does not use contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
### E8-4Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | | |
|-----------------------|---------------------------------|----------|-------------------|---|----|----|--------|--------------------|-----------------|
| | General | Specific | B | M | PW | CW | Color* | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging & Other | Fetal / Obstetrics | | P | P | P | | P | Note[1] | Note[2] [3] |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-vaginal | | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) *** | | P | P | P | | P | Note[1] | Note[2] [3] |
| Cardiac | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral 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
Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
| ** Small Organ includes Thyroid, Testes, Breast. |
|--------------------------------------------------|
| ***Other use includes Urology and Gynecology. |
| [1]: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging. This feature does not use contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
### E10-3BQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | Mode of Operation | | | | | | |
|--------------------------|---------------------------------|-------------------|---|----|----|---------------------|-----------------------|--------------------|
| General | Specific | B | M | PW | CW | Color*<br>(Specify) | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) ** | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-vaginal | P | P | P | | P | Note[1] | Note[2] [3] |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| 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
Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
| ** Small Organ includes Thyroid, Testes, Breast. | ***Other use includes Urology and Gynecology. |
|--------------------------------------------------|-----------------------------------------------|
|--------------------------------------------------|-----------------------------------------------|
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
## E10-3HQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | | |
|------------------------|--------------------------|---------------------------------|-------------------|---|----|----|--------|--------------------|-----------------|
| | General | Specific | B | M | PW | CW | Color* | Combined (Specify) | Other (Specify) |
| | Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal Imaging<br>& Other | Fetal / Obstetrics | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Abdominal | | | | | | | |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Specify) ** | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Trans-vaginal | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Trans-urethral | | | | | | | |
| | | Musculo-skeletal(Conventional) | | | | | | | |
| | | Musculo-skeletal (Superficial) | | | | | | | |
| | | Intravascular | | | | | | | |
| | | Other (Specify) *** | P | P | P | | P | Note[1] | Note[2] [3] |
| | 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
Note: * Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
** Small Organ includes Thyroid, Testes, Breast. ***Other use includes Urology and Gynecology.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
### MC8-4Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|----------------------|---------------------------------|-------------------|---|----|----|--------|--------------------|-----------------|
| | General | Specific | B | M | PW | CW | Color* | Combined (Specify) | Other (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | | Fetal / Obstetrics | | | | | | | |
| | | Abdominal | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Small Organ (Specify) ** | | | | | | | |
| | | Neonatal Cephalic | N | N | N | N | N | Note[1] | Note[2] [3] |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Musculo-skeletal (Conventional) | P | P | P | | P | Note[1] | Note[2] [3] |
| | | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] |
| | | 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 | Note[1] | Note[2] [3] |
| | | 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
Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
***Other use includes Gynecology. ** Small Organ includes Thyroid, Testes, Breast.
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
### MC9-3TQ Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | | |
|-----------------------|---------------------------------|---|-------------------|----|----|--------|--------------------|-----------------|--|
| | Specific | B | M | PW | CW | Color* | Combined (Specify) | Other (Specify) | |
| General | Ophthalmic | | | | | | | | |
| | Fetal / Obstetrics | | | | | | | | |
| | Abdominal | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Small Organ (Specify) ** | | | | | | | | |
| Fetal Imaging & Other | Neonatal Cephalic | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | Note[1] | Note[2] [3] | |
| | Intravascular | | | | | | | | |
| | Other (Specify) *** | | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral vascular | Peripheral vascular | P | P | P | | P | Note[1] | Note[2] [3] | |
| 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
Note:
* Color Doppler includes Color imaging, PDI(Power Doppler Imaging) and DPDI(Directional Power Doppler Imaging)
| [1]: Combined mode: B+M, B+PW,<br>B+Color, B+PDI/DPDI, B+Color+PW,<br>B+PDI/DPDI +PW | [2]: Biopsy Guidance | [3]: Harmonic Imaging.<br>This feature does not use<br>contrast agent. | [4]: 3D/4D |
|--------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------|------------|
| [5]: TDI. | [6]: Anatomic M | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{16}------------------------------------------------
### P5-1Q Transducer on Acclarix AX3 Series/Acclarix LX3 Series
| | Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|----------------------|---------------------------------|-------------------|---|----|----|--------|-----------------------|--------------------|
| | General | Specific | B | M | PW | CW | Color* | Combined<br>(Specify) | Other<br>(Specify) |
| | Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | | Fetal / Obstetrics | | | | | | | |
| | | Abdominal | P | P | P | P | P | Note[1] | Note[2] [3] |
| | | Intra-operative (Specify) | | | | | | | |
| | | Intra-operative (Neuro logical) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | |…
