(55 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a "Diagnostic Ultrasound System" intended for "ultrasound evaluations." It is used to "acquire and display ultrasound data," indicating a diagnostic rather than therapeutic purpose.
Yes
The 'Device Description' explicitly states, "Acclarix AX4/ Acclarix LX4 is a software controlled Diagnostic Ultrasound System."
No
The device description explicitly states it "consists of a main unit along with associated transducers," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this is a Diagnostic Ultrasound System. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
- Intended Use: The intended use describes various clinical applications for imaging different parts of the body (abdominal, cardiac, etc.) using ultrasound, not for analyzing biological samples.
- Device Description: The description mentions a "software controlled Diagnostic Ultrasound System" with a main unit and transducers, consistent with an ultrasound machine.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, based on the provided information, this device is a diagnostic imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 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. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, IYN
Device Description
Acclarix AX4/ Acclarix LX4 is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Gynecological, Obstetric, Cardiac, Breast, Testes, Thyroid, Urological, Musculoskeletal, Peripheral vascular, Cephalic (neonatal and adult).
Indicated Patient Age Range
Pediatric, Neonatal, Adult
Intended User / Care Setting
Qualified physician or allied health professional in a prescription use environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test: The Acclarix AX4 and Acclarix LX4 Diagnostic Ultrasound Systems comply with: (1) ANSI/AAMI ES60601-1 Electrical Safety (2) IEC 60601-1-2 Electromagnetic Compatibility (3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008 (5) NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3. The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10. The tests were selected to show substantial equivalence between the subject device and the predicate. The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices. Clinical testing is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.
Edan Instruments, Inc. % Ms. Melody Huang Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, 518122 Guangdong CHINA
March 28, 2019
Re: K190186
Trade/Device Name: Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: January 29, 2019 Received: February 1, 2019
Dear Ms. Huang:
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
1
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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K190186
Device Name Acclarix AX4 Diagnostic Ultrasound System/Acclarix LX4 Diagnostic Ultrasound System
Indications for Use (Describe)
The 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
| Clinical Application | | Mode of Operation | | | | | | Other
(Specify) [2]3 |
|-----------------------------|---------------------------------|------------------------|---------------------|----|----|-------|---------------------------|------------------------------|
| General | Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal
Imaging
& 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 | P | P | P | P | P | P | P |
| | 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 5 |
| | Pediatric Cardiac | P | P | P | P | P | P | P 5 |
| | Cardiac | Intravascular(Cardiac) | | | | | | |
| | | Trans-esoph.(Cardiac) | | | | | | |
| | | Intra- cardiac | | | | | | |
| | | Peripheral
vascular | Peripheral vascular | P | P | P | | P |
| | | | Other (Specify) | | | | | |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 Diagnostic Ultrasound System
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, Lung Note
| ** Other use includes Urology, Gynecology and 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. ______________________________________________________________________________________________________________________________________________________________________________
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | ||||||||
| Ophthalmic | Specific | |||||||
| 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 Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| 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 | |||||||
| vascular | Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with C5-2Q Transducer
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)
5
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (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 | P | |
| Fetal Imaging | Neonatal Cephalic | |||||||
| & Other | Adult Cephalic | |||||||
| 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) ** | ||||||||
| 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) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with L12-5Q Transducer
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, Lung. 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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | |
| 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) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | P | P | P | P | P | P | |
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with MC8-4Q Transducer
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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with E8-4Q Transducer
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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | P | P | P | P | P | P | ||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| vascular | Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with L17-7SQ Transducer
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)
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (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 | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| 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) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with C5-2MQ Transducer
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 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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| 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 | ||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | P | P | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| 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 | |||||||||
| vascular | Peripheral vascular | ||||||||
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with P5-1Q Transducer
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)
11
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | P |
| Adult Cephalic | ||||||||
| 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 | ||||||||
| vascular | Peripheral vascular | P | P | P | P | P | P | P |
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix AX4 with MC9-3TQ Transducer
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)
12
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify)[2]3 | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal / Obstetrics | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | P | P | P | P | P | P | P | |
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Specify) * | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | P | P | P | P | P | P | P | |
| Trans-vaginal | P | P | P | P | P | P | P | |
| 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 | |
| Cardiac | Adult Cardiac | P | P | P | P | P | P | P 5 |
| Pediatric Cardiac | P | P | P | P | P | P | P 5 | |
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | P | P | P | P | P | P | P |
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 Diagnostic Ultrasound System
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, B+CW, B+Color+CW, B+PDI/DPDI+CW,
Note * Small Organ includes Thyroid, Testes, Breast, Lung
** Other use includes Urology, Gynecology and 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 CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
13
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| 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 | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with C5-2D Transducer
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)
14
| 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 | P | |
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| 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) ** | ||||||||
| 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) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with L12-5D Transducer
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, Lung. 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)
15
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | P | P | P | P | P | P | |
| 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) ** | 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 | |
| vascular | Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with MC8-4D Transducer
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)
16
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| General | Specific | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| Other (Specify) | ||||||||
| vascular |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with E8-4D Transducer
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
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
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & 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 | ||||||||
| vascular | Peripheral vascular | P | P | P | P | P | P | |
| Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with L17-7SD Transducer
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 CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
18
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (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 Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| 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) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with C5-2MD Transducer
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 Gynecology
[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
1
(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)
19
| 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 | |||||||
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| 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 | ||||||||
| vascular | Peripheral vascular | |||||||
| vascular | Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with P5-1D Transducer
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+CW.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)
20
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | Other |
| (Specify) [1] | (Specify) [2][3] | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| 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) ** | P | P | P | P | P | P | ||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| vascular | Other (Specify) |
Diagnostic Ultrasound Indications for Use Form Acclarix LX4 with MC9-3TD Transducer
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
Note Small Organ Includes Thyroid, Testes, Breast
** 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)
21
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel: +86-755-2685 8736 Fax: +86-755-2689 8330 |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Melody Huang |
| Preparing date: | Jan. 29, 2019 |
| 2. Device name and
classification: | Device Name: Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4
Diagnostic Ultrasound System
Model: Acclarix AX4, Acclarix LX4
Classification Name/ Product code:
21 CFR 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic / IYN
21 CFR 892.1560, Ultrasonic, Pulsed echo, Imaging / IYO
21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic / ITX
Regulatory Class: Class II |
| 3.Premarket Notification
Class III Certification
and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, Acclarix AX8 Diagnostic Ultrasound System, cleared
under K180862 (Primary)
2) Edan Instruments, Acclarix LX8 Diagnostic Ultrasound System, cleared
under K180862 (Primary)
3) Edan Instruments, Acclarix AX4 Diagnostic Ultrasound System, cleared
under K171900 (Reference) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for an updated version of the Acclarix AX4 Diagnostic Ultrasound
Systems and the Acclarix LX4 (new model) Diagnostic Ultrasound Systems. |
| 6.Pre-Submission,
IDE | Not applicable, there is no pre-submission. |
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- Acclarix AX4/ Acclarix LX4 is a software controlled Diagnostic Ultrasound 7. Device Description: System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
The Acclarix AX4 Diagnostic Ultrasound System/Acclarix LX4 Diagnostic 8. Indication for Use 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
9. Predicate Device Comparison
Edan Instruments' Acclarix AX4 and Acclarix LX4 Diagnostic Ultrasound System are comparable to the following legally marketed devices in the table below:
| No. | Device Name & Model | K Number | Manufacture |
|---|---|---|---|
| 1 | Acclarix AX8 Diagnostic Ultrasound System | ||
| (Primary) | K180862 | Edan Instruments, Inc. | |
| 2 | Acclarix LX8 Diagnostic Ultrasound System | ||
| (Primary) | K180862 | Edan Instruments, Inc. | |
| 3 | Acclarix AX4 Diagnostic Ultrasound System | ||
| (Reference) | K171900 | Edan Instruments, Inc. |
The subject device Acclarix AX4/ Acclarix LX4 is same as the primary predicated device Acclarix AX8/
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Acclarix LX8 (K180862) in items such as:
-
- Intended Use/ Indications for Use;
-
- Mode of Operations;
-
- Transducer Types
-
- Acoustic Output, which are below the limits of FDA;
-
- The materials of transducers and needle-guided brackets;
The differences of subject device Acclarix AX4/ Acclarix LX4 with the primary predicated device Acclarix AX8/ Acclarix LX8 (K180862) are described as below:
-
- The subject device does not support five transducers that are already cleared in the primary predicated device Acclarix AX8/ Acclarix LX8 (K180862).
-
- Safety standards that the subject device is designed in compliance with do not include UD3 standard because it has not been recognized by FDA, while the safety standards of primary predicated device Acclarix AX8/ Acclarix LX8 (K180862) include UD3 standard.
-
- IEC 60601-1-2 and IEC 60601-2-37 standards have been updated to the latest version.
The subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
10. Performance Data:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The Acclarix AX4 and Acclarix LX4 Diagnostic Ultrasound Systems comply with:
- (1) ANSI/AAMI ES60601-1 Electrical Safety
- (2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- (4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008
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(5) NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10
The tests were selected to show substantial equivalence between the subject device and the predicate.
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.
11. Conclusion
Verification and validation testing has been conducted on the Acclarix LX4 Diagnostic Ultrasound Systems. This premarket notification submission demonstrates that Acclarix LX4 and Acclarix LX4 Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices.