(102 days)
Not Found
No
The document explicitly states "This system in no way interprets these images or provides a medical diagnosis of the patient being examined," and there are no mentions of AI, ML, or related terms in the device description or features. The image processing mentioned is standard smoothing and edge enhancement, not indicative of AI/ML.
No
The device is described as a "Diagnostic Ultrasound System" intended for "ultrasound evaluation/clinical analysis" and "diagnosis of patients," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system can be used for "diagnosis of patients," and the "Device Description" refers to it as a "Diagnostic Ultrasound System" intended to "enhance the diagnostic utility and confidence provided by the system."
No
The device description clearly outlines hardware components such as a touch screen display, transducer sockets, and mentions transducers with specific frequency ranges. It is described as a portable ultrasound imaging instrument, indicating a physical device beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states the system is a "general-purpose ultrasonic" device that uses "sound echoes" to produce images. This is an in vivo (within the living body) imaging modality.
- Intended Use: The intended use describes non-intrusive applications for ultrasound evaluation and clinical analysis of the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a diagnostic imaging system that operates by sending and receiving sound waves within the patient's body to create images for interpretation by a qualified medical professional. This is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the BenQ diagnostic ultrasound:
- Compact size with 1 transducer sockets. Convertible cart-based system design.
- 2D (B&M mode) with harmonic imaging
- Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
- 13.3″ LCD supporting wide-viewing angle with multi-touch
- Support 64 channels, support up to 128 elements probes, and easy maintenance.
- High density transducers with frequency range from 2 to 15 MHz
- Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.
Mentions image processing
Yes, "Image Processing: Smoothing, edge enhancement" and "Image Processing: QScan for smoothing and edge enhancement"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial, Nerve, Renal, Urology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician/operator; clinics, hospitals, and clinical point of care.
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)
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The T3300 and its applications comply with voluntary standards.
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.
Not Found
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
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 followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
August 27th, 2018
Qisda Corporation % Mr. Johnson Sheu Official Correspondent No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist, Taoyuan City, 333 TAIWAN
Re: K181313
Trade/Device Name: BenQ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 26, 2018 Received: July 31, 2018
Dear Mr. Sheu:
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 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
1
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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
Jeff Balyso
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181313
Device Name BenQ Diagnostic Ultrasound System
Indications for Use (Describe)
The system is a general-purpose ultrasonic intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point of care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed. The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
The following table provides Diagnostic Ultrasound Indications for the transducers offered with the BenQ Diagnostic Ultrasound System.
| Indications for Use | Supporting Transducers |
|---|---|
| Cardiac Adult | P42B6 |
| Obstetric | C62B |
| Urology | C62B |
| Abdomen | C62B |
| Gynecology | C62B |
| Renal | C62B |
| Musculoskeletal (Conventional) | L154BH |
| Peripheral Vessel (Carotid, Venous, Arterial) | L154BH |
| Small Parts (Breast, Thyroid) | L154BH |
| Nerve | L154BH |
| 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.
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3
Diagnostic Ultrasound Indications for Use Form
T3300 Diagnostic Doppler Ultrasound System System: T3300 Diagnostic Ultrasound Pulsed Echo System T3300 Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | 2D | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | CPA | Other* | ||||||
| Combined | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | Fetal | N | N | N | N | N | Note 1 | N | |
| Imaging & | Abdominal | N | N | N | N | N | Note 1 | N | |
| Other | Intra-operative | ||||||||
| Specify | |||||||||
| Intra-operative | |||||||||
| Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testes) | N | N | N | N | N | Note 1 | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non- | |||||||||
| Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | Note 1 | N | ||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN, | |||||||||
| Urology, Nerve) | N | N | N | N | N | Note 1 | N | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | N | |
| Vessel | Other (specify) |
N = new indication; P = previously cleared by FDA E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/Color; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Indications For Use
Page 2 of 5
4
BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Diagnostic Ultrasound Indications for Use Form
Transducer: C62B Curved Linear Array 2-6MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (TRACK 1 | ||||||||
| ONLY) | Specific | |||||||
| (TRACKS 1 & 3) | 2D | M | PW | |||||
| Doppler | Color | |||||||
| Doppler | CPA | Other* | ||||||
| Combined | Tissue | |||||||
| Harmonic | ||||||||
| Imaging | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | N | N | N | N | N | Note1 | N |
| Abdominal | N | N | N | N | N | Note1 | N | |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Ob/GYN, Urology) | N | N | N | N | N | Note1 | N | |
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 5
5
Diagnostic Ultrasound Indications for Use Form
Transducer: L154BH Linear Array 4-15MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (TRACK 1 | ||||||||
| ONLY) | Specific | |||||||
| (TRACKS 1 & 3) | 2D | M | PW | |||||
| Doppler | Color | CPA | Other* | |||||
| Combined | Tissue | |||||||
| Harmonic | ||||||||
| Imaging | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | Note1 | N | |
| Intra-operative Specify | ||||||||
| Intra-operative Neuro | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testes) | N | N | N | N | N | Note1 | N | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph.(non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | N | N | N | Note1 | N | |
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Nerve) | N | N | N | N | N | Note1 | N | |
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note1 | N |
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CPA; 2D/Color /PW Doppler and 2D/CPA/PW Doppler
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 of 5
6
Diagnostic Ultrasound Indications for Use Form
Transducer: P42B6 Phase Array 64 elements 2-4MHz Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | 2D | M | PW | ||||||
| Doppler | CW | ||||||||
| Doppler | Color | CPA | Other* | ||||||
| Combined | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testes) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non- | |||||||||
| Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Combined includes: 2D/M; 2D/PW Doppler; 2D/CW Doppler;2D/Color; 2D/CPA; 2D/Color /PW Doppler; 2D/Color /CW Doppler; 2D/CPA/CW Doppler and 2D/CPA/PW Doppler
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 5 of 5
7
PREMARKET NOTIFICATION [510(k)] Summary
| Company Name: | Qisda Corporation
No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,
Taoyuan City, Taiwan |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Johnson Sheu |
| Device Name: | BenQ Diagnostic Ultrasound System |
| Device Model: | T3300 |
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulation Number: 21 CFR 892.1550 |
Primary Predicate Device :
| 510(k) Number | Product Name | Manufacturer name | Regulation Number | Product Code(s) |
|---|---|---|---|---|
| K172056 | InnoSight Diagnostic | |||
| Ultrasound System | Qisda Corporation | 21 CFR 892.1560 | 90-IYO | |
| 90-IYN | ||||
| 90-ITX |
Registration Number: 3010220244
Factory Location: Qisda Corporation No.159,Shanying Rd., Shan-Ting Li, Gueishan Dist., Taoyuan City,Taiwan
Product Code: IYN, IYO, ITX
Reason for Submission:
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Predicate Device Comparison:
The InnoSight is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device
8
BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
| Qisda | Predicate Device | Submission Device |
|---|---|---|
| Product Name | InnoSight Diagnostic Ultrasound System | BenQ Diagnostic Ultrasound System |
| 510(k) Number | K172056 | Pending |
| Indications for Use | InnoSight Diagnostic Ultrasound System is intended for | |
| diagnostic ultrasound imaging in B (2D), M-Mode, PW | ||
| Doppler, CPA, Tissue Harmonic imaging and Color | ||
| Doppler modes. It is indicated for diagnostic | ||
| ultrasound imaging and fluid flow analysis in the | ||
| following applications: Fetal, Abdominal, Small | ||
| Organ(Breast, Thyroid, testes), trans-rectal, | ||
| trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac | ||
| Adult and Peripheral Vessel. The clinical environments | ||
| where the system can be used include clinics, | ||
| hospitals, and clinical point-of-care for diagnosis of | ||
| patients. | The system is a general-purpose ultrasonic imaging | |
| instrument intended for use by a qualified physician for | ||
| ultrasound evaluation/clinical analysis etc. It can be | ||
| used in non-intrusive applications, including Abdomen, | ||
| Cardiology, Gynecology, Obstetric, Breast, Thyroid, | ||
| Musculoskeletal, Vascular (Carotid, Venous, Arterial), | ||
| Nerve, Renal, and Urology. The clinical environments | ||
| where the system can be used include clinics, | ||
| hospitals, and clinical point of care for diagnosis of | ||
| patients | ||
| Design | Based on 64 channel full digital beam former. | Based on 64 channel full digital beam former. |
| Operating Controls | Autocorrelation for color processing and FFT for pulse | |
| and CW Doppler processing. | ||
| Supporting both Linear, Curve linear and Phase array | ||
| probes from 2 to 15 MHz. Cine play back capability and | ||
| Image file archive Software upgrade with USB flash | ||
| drive. Digital Scan Converter 1366x768 | ||
| § TGC 8 slider, +/- 22.5 dB | Autocorrelation for color processing and FFT for pulse | |
| and CW Doppler processing. | ||
| Supporting both Linear, Curve linear and Phase array | ||
| probes from 2 to 15 MHz. Cine play back capability and | ||
| Image file archive Software upgrade with USB flash | ||
| drive. Digital Scan Converter 1366x768 | ||
| § TGC 8 slider, +/- 22.5 dB | ||
| § Depth Range: 1 to 28 cm | § Depth Range: 1 to 28 cm | |
| § Image sector size: 46 lines to full B (256 lines) | § Image sector size: 46 lines to full B (256 lines) | |
| § Image Sector position: Steering within full maximum | § Image Sector position: Steering within full maximum | |
| § B orientation flip: L/R key with marking on the screen | § B orientation flip: L/R key with marking on the screen | |
| § B Dynamic range control: preset 100 levels | § B Dynamic range control: preset 100 levels | |
| § Gray Scale Control: 5 levels | § Gray Scale Control: 5 levels | |
| § Focal Number: 10 focal zone setting | § Focal Number: 10 focal zone setting | |
| § B persistence: 10 levels | § B persistence: 10 levels | |
| § Image Processing: Smoothing, edge enhancement | § Image Processing: Smoothing, edge enhancement | |
| § PW sweeping speed 1,2,4,8 sec over display. | § PW sweeping speed 1,2,4,8 sec over display. | |
| § PW Wall filter setting: 20 levels | § PW Wall filter setting: 20 levels | |
| § PW sample volume: 0.23 to 20 mm | § PW sample volume: 0.23 to 20 mm | |
| § PW/B update: with UPDATE key | § PW/B update: with UPDATE key | |
| § PW cursor steering: Steer key | § PW cursor steering: Steer key | |
| § PW angle correction: - 72,0,72 degree user control | § PW angle correction: - 72,0,72 degree user control | |
| § PW spectrum dynamic range: 8 preset curve over | ||
| 10-80 dB | ||
| § Spectrum baseline shift and invert | § PW spectrum dynamic range: 8 preset curve over | |
| 10-80 dB | ||
| § Spectrum baseline shift and invert | ||
| § M Process: Peak, Mean | § M Process: Peak, Mean | |
| § Color ROI setting: Touch and drag to control size and | ||
| position | ||
| § Color steering on flat probe: +/- 15 | § Color ROI setting: Touch and drag to control size and | |
| position | ||
| § Color steering on flat probe: +/- 15 | ||
| § Color Wall Filter: Color wall filter with 20 settings | § Color Wall Filter: Color wall filter with 20 settings | |
| § Color & B priority: C-B priority Key | § Color & B priority: C-B Reject Key | |
| § Zoom factor: Up to 5x | § Zoom factor: Up to 5x | |
| § Freeze control: Touch freeze key | § Freeze control: Touch freeze key | |
| § Cine control: step, play backward, play continuously | § Cine control: step, play backward, play continuously | |
| Qisda | Predicate Device | Submission Device |
| Safety Compliance | IEC 60601-1 International Electrotechnical Comission; | |
| Medical Electrical Equipment - Part 1 | ||
| IEC60601-2 International Electrotechnical Comission; | ||
| Electromagnetic Compatibility | ||
| IEC 60601-2-37 International Electrotechnical | ||
| Comission; Medical Electrical Equipment - Part 2-37 | IEC 60601-1 International Electrotechnical Comission; | |
| Medical Electrical Equipment - Part 1 | ||
| IEC60601-2 International Electrotechnical Comission; | ||
| Electromagnetic Compatibility | ||
| IEC 60601-2-37 International Electrotechnical | ||
| Comission; Medical Electrical Equipment - Part 2-37 | ||
| Patient Contact | ||
| Materials | RTV664+Ultrason S2010 silicon rubber complies with | |
| ISO10993-5and ISO10993-10 | Housing: PC/ABS Lens: SILICONE are compliance with | |
| ISO 10993-5 and ISO 10993-10 | ||
| Operation Mode | B (2-D), M, CFM, CPA, PW,CW, Tissue Harmonic Image | |
| and combine mode | B (2-D), M, Color(CFM), Power(CPA), PW,CW, | |
| THI(Tissue Harmonic Image) and combine mode | ||
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; | |
| 2-D/Pulsed Doppler and Triplex 2-D/CD/Pulsed | ||
| Doppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode; | |
| 2-D/Pulsed Doppler and Triplex 2-D/Color/Pulsed | ||
| Doppler image formats; Dual B and Color in real time | ||
| Display Annotations | Time/date/year; transducer type; power output in %; | |
| frames per second; persistence; and compression | ||
| settings; image depth; patient name and ID; institution | ||
| name; focal position; TGC curve display; Doppler & M | ||
| scale in sec; Doppler angle correction cursor; free form | ||
| annotation anywhere on image; touch controlled; | ||
| selective or global erase of the display annotations, | ||
| body markers with transducer annotations | Time/date/year; transducer type; power output in %; | |
| frames per second; persistence; and compression | ||
| settings; image depth; patient name and ID; institution | ||
| name; focal position; TGC curve display; Doppler & M | ||
| scale in sec; Doppler angle correction cursor; free form | ||
| annotation anywhere on image; touch controlled; | ||
| selective or global erase of the display annotations, | ||
| body markers with transducer annotations | ||
| Display Monitor | 11.6" LCD Touch Screen | 13.3" LCD Touch Screen |
| Measurements | Distance; area; Volume; circumference; Heart Rate; | |
| calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascular | ||
| package. | Distance; area; Volume; circumference; Heart Rate; | |
| calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascular | ||
| package. | ||
| Transducer Types & | ||
| Connectors | Convex, Phase array, and Linear array probes; | |
| Single-port connector connect 1 transducer | Convex, Phase array, and Linear array probes; | |
| Single-port connector connect 1 transducer | ||
| Transducer List | * C6-2 |
- C9-4v
- L12-4
- S4-2 | * C62B
- L154BH
- P42B6 |
| System frequency
range | 1.3 to 14.4 MHz | 1.3 to 14.4 MHz |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric
material in the transducer and detect the reflected
echo to construct the 2-D B-mode, Doppler color, and
Doppler spectrum image for diagnostic purpose. | Applying high voltage burst to the Piezoelectric
material in the transducer and detect the reflected
echo to construct the 2-D B-mode, Doppler color, and
Doppler spectrum image for diagnostic purpose. |
| Users / Sites | Hospitals, clinics usage | Hospitals, clinics usage |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2
maximum, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical
Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2
max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2
maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical
Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2
max |
| Dimensions /
Weight
Power
Requirements | Dimension: Height 223.2 mm Width 319.6 mm Depth
31.8 mm Weight: 2.46 kg
Power requirements: 100240 Volts AC, 1.7 Amps240 Volts AC, 1.6A Max.
Power Consumption: 65 watts max.
Operating temperature 10-40° C; relative humidity
20-85%; | Dimension: Height 238.5 mm, Width 348.2 mm
Depth(Thickness): 38.5 mm. Weight: 2.6 kg
Power requirements: 100
Power Consumption: 65 watts max
Operating temperature 10-40° C; relative humidity
20-85%; |
| Peripherals and
Accessories | LAN, USB thermal Printer, USB flash mobile drive ,
HDMI video output | LAN, USB thermal Printer, USB flash mobile drive ,
HDMI video output |
9
BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
General Device Description:
The BenQ Diagnostic Ultrasound System (hereinafter called "system") is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis. The user interface is touch screen with 13.3" display. The all-digital architecture with progressive dynamic receive focusing allows the
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BenQ Diagnostic Ultrasound System, Model T3300 510(k) Submission
system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the BenQ diagnostic ultrasound:
- Compact size with 1 transducer sockets. Convertible cart-based svstem design.
- . 2D (B&M mode) with harmonic imaging
- Color Flow Imaging, Pulsed Wave Spectral Doppler, Steerable Continuous Wave Doppler, Power Doppler
- 13.3″ LCD supporting wide-viewing angle with multi-touch
- Support 64 channels, support up to 128 elements probes, and easy maintenance.
- High density transducers with frequency range from 2 to 15 MHz
- Full patient database solutions: DICOM3.0, MP4 /PNG, USB3.0, SSD, PDF report, etc.
Indications for Use:
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for ultrasound evaluation/clinical analysis etc. It can be used in non-intrusive applications, including Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Vascular (Carotid, Venous, Arterial), Nerve, Renal, and Urology. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
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| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and
Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time. | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Description of
Transducers | L154BH Linear Array 4-15MHz
C62B Curved Linear Array 2-6MHz
P42B6 Phased Array 2-4MHz | |
| Measurements | Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RI,
Cardiac, OB/GYN and Vascular package. | |
| Principle of
Operation | Applying high voltage burst to the Piezoelectric material in the transducer
and detect the reflected echo to construct the 2-D B-mode, Doppler color,
and Doppler spectrum image for diagnostic purpose. | |
| Operating
Controls | TGC 8 slider Depth Range: 1 to 28 cm Image sector size: 46 lines to full B (256 lines) Image Sector position: moving within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 100 levels Gray Scale Control: 5 Settings Focal Number: up to 10 focal zone setting B persistence: 10 levels Image Processing: QScan for smoothing and edge enhancement PW sweeping speed 1x,1/2x,1/4x,1/8x over display. PW Wall filter setting: 20 settings PW sample volume: 0.2 to 20mm PW/B update: with UPDATE key PW cursor steering: Steer key PW angle correction: +/- 72 degree user control PW spectrum dynamic range: 8 preset curve Spectrum baseline shift and invert Color ROI setting: Touch and drag to control size and position Color steering on flat probe: +/- 15 Color Wall Filter: Color wall filter with 20 settings Color & B priority: C-B priority key Color Packet size: preset per Exam range up to 11 Zoom factor: Up to 5x Freeze control: Touch freeze key Cine control: step, play continuously | |
| Acoustic
Output | Conform to IEC 60601-2-37 and AIUM UD2 requirements for all modes of all
probes | |
Technological Characteristics:
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Summary of Non-Clinical Test:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The T3300 and its applications comply with voluntary standards.
| Recognition
| Number | Regulations No./Version | Recognition Standard |
|---|---|---|
| 19-4 | ANSI | |
| AAMI ES60601-1:2005/(R)2012 | ||
| and A1:2012, | ||
| C1:2009/(R)2012 and | ||
| A2:2010/(R)2012 | ||
| (Consolidated Text) | Medical electrical equipment - Part 1: | |
| General requirements for basic safety | ||
| and essential performance (IEC | ||
| 60601-1:2005, MOD). (General II | ||
| (ES/EMC)) | ||
| 19-1 | IEC 60601-1-2 Edition 3: | |
| 2007-03 | Medical electrical equipment - Part 1-2: | |
| General requirements for basic safety | ||
| and essential performance - Collateral | ||
| standard: Electromagnetic compatibility |
- Requirements and tests. (General II
(ES/EMC) |
| 12-293 | IEC 60601-2-37 Edition 2.1
2015 | Medical electrical equipment - Part 2-37:
Particular requirements for the basic
safety and essential performance of
ultrasonic medical diagnostic and
monitoring equipment |
| 2-220 | ISO 10993-1 Fourth Edition
2009-10-15 | Biological evaluation of medical devices -
Part 1: Evaluation and testing within a
risk management process [Including:
Technical Corrigendum 1 (2010)] |
| 12-105 | UD 2-2004 (R2009) | Acoustic Output Measurement Standard
for Diagnostic Ultrasound Equipment
Revision 3. (Radiology) |
| 13-79 | IEC 62304:2015 | Medical device software - Software life
cycle processes |
Summary of Clinical Tests:
The subject of this premarket submission, T3300, is not required clinical studies to support substantial equivalence.
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Conclusion:
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. It is considered that the T3300 to be as safe, as effective and performance is substantially equivalent to the predicate devices. Therefore, it is concluded that this device is safe and effective for its intended use.