BenQ Diagnostic Ultrasound System

K181313 · Qisda Corporation · IYN · Aug 27, 2018 · Radiology

Device Facts

• Record ID: K181313
• Device Name: BenQ Diagnostic Ultrasound System
• Applicant: Qisda Corporation
• Product Code: IYN · Radiology
• Decision Date: Aug 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended 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.

Device Story

Portable diagnostic ultrasound system (T3300) for clinical imaging; utilizes 64-channel digital beamformer to process sound echoes from piezoelectric transducers (2-15 MHz). Inputs: acoustic signals from transducers; outputs: 2D (B-mode), M-mode, Color Flow, Power Doppler, Pulsed Wave, and Continuous Wave Doppler images on 13.3" LCD touchscreen. Operated by trained physicians/clinicians in hospitals/clinics. System provides raw images for interpretation; does not provide automated diagnosis. Features include cine playback, image archiving, and DICOM connectivity. Benefits include portable, non-intrusive diagnostic evaluation of various anatomical structures.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including acoustic output measurements (IEC 60601-2-37, AIUM UD2), biocompatibility (ISO 10993-1), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

64-channel digital beamformer; transducers: C62B (curved linear), L154BH (linear), P42B6 (phased array); frequency 2-15 MHz; materials: PC/ABS housing, silicone lens (ISO 10993-5/10 compliant); modes: 2D, M, PW/CW Doppler, Color, Power, THI; connectivity: DICOM 3.0, USB 3.0, HDMI; power: 100-240V AC; display: 13.3" LCD touchscreen.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in patients requiring evaluation of the abdomen, heart, gynecological/obstetric structures, breast, thyroid, musculoskeletal system, peripheral vessels (carotid, venous, arterial), nerves, renal system, and urological structures. Used in clinics, hospitals, and point-of-care settings by trained physicians.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• InnoSight Diagnostic Ultrasound System (K172056)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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#### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | CW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>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<br>Specify | | | | | | | | |
| | Intra-operative<br>Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | N | N | N | | N | N | Note 1 | N |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-<br>Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | N |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN,<br>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

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#### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color<br>Doppler | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>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<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(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<br>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)

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#### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | |
| | Abdominal | N | N | N | N | N | Note1 | N |
| | Intra-operative Specify | | | | | | | |
| | Intra-operative Neuro | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>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<br>(Conventional) | N | N | N | N | N | Note1 | N |
| | Musculo-skeletal<br>(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<br>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)

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#### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | 2D | M | PW<br>Doppler | CW<br>Doppler | Color | CPA | Other*<br>Combined | Tissue<br>Harmonic<br>Imaging |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast,<br>thyroid, testes) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-<br>Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(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<br>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)

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# PREMARKET NOTIFICATION [510(k)] Summary

| Company Name: | Qisda Corporation<br>No.157, Shanying Rd., Shan-Ting Li, Gueishan Dist.,<br>Taoyuan City, Taiwan |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Johnson Sheu <[e-mail]> |
| Device Name: | BenQ Diagnostic Ultrasound System |
| Device Model: | T3300 |
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology<br>Regulation Name: Ultrasonic Pulsed Doppler Imaging System<br>Regulation Number: 21 CFR 892.1550 |

# Primary Predicate Device :

| 510(k) Number | Product Name | Manufacturer name | Regulation Number | Product Code(s) |
|---------------|-------------------------------------------|-------------------|-------------------|----------------------------|
| K172056 | InnoSight Diagnostic<br>Ultrasound System | Qisda Corporation | 21 CFR 892.1560 | 90-IYO<br>90-IYN<br>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

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#### 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<br>diagnostic ultrasound imaging in B (2D), M-Mode, PW<br>Doppler, CPA, Tissue Harmonic imaging and Color<br>Doppler modes. It is indicated for diagnostic<br>ultrasound imaging and fluid flow analysis in the<br>following applications: Fetal, Abdominal, Small<br>Organ(Breast, Thyroid, testes), trans-rectal,<br>trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac<br>Adult and Peripheral Vessel. The clinical environments<br>where the system can be used include clinics,<br>hospitals, and clinical point-of-care for diagnosis of<br>patients. | The system is a general-purpose ultrasonic imaging<br>instrument intended for use by a qualified physician for<br>ultrasound evaluation/clinical analysis etc. It can be<br>used in non-intrusive applications, including Abdomen,<br>Cardiology, Gynecology, Obstetric, Breast, Thyroid,<br>Musculoskeletal, Vascular (Carotid, Venous, Arterial),<br>Nerve, Renal, and Urology. The clinical environments<br>where the system can be used include clinics,<br>hospitals, and clinical point of care for diagnosis of<br>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<br>and CW Doppler processing.<br>Supporting both Linear, Curve linear and Phase array<br>probes from 2 to 15 MHz. Cine play back capability and<br>Image file archive Software upgrade with USB flash<br>drive. Digital Scan Converter 1366x768<br>§ TGC 8 slider, +/- 22.5 dB | Autocorrelation for color processing and FFT for pulse<br>and CW Doppler processing.<br>Supporting both Linear, Curve linear and Phase array<br>probes from 2 to 15 MHz. Cine play back capability and<br>Image file archive Software upgrade with USB flash<br>drive. Digital Scan Converter 1366x768<br>§ 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<br>10-80 dB<br>§ Spectrum baseline shift and invert | § PW spectrum dynamic range: 8 preset curve over<br>10-80 dB<br>§ Spectrum baseline shift and invert |
| | § M Process: Peak, Mean | § M Process: Peak, Mean |
| | § Color ROI setting: Touch and drag to control size and<br>position<br>§ Color steering on flat probe: +/- 15 | § Color ROI setting: Touch and drag to control size and<br>position<br>§ 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;<br>Medical Electrical Equipment - Part 1<br>IEC60601-2 International Electrotechnical Comission;<br>Electromagnetic Compatibility<br>IEC 60601-2-37 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part 2-37 | IEC 60601-1 International Electrotechnical Comission;<br>Medical Electrical Equipment - Part 1<br>IEC60601-2 International Electrotechnical Comission;<br>Electromagnetic Compatibility<br>IEC 60601-2-37 International Electrotechnical<br>Comission; Medical Electrical Equipment - Part 2-37 |
| Patient Contact<br>Materials | RTV664+Ultrason S2010 silicon rubber complies with<br>ISO10993-5and ISO10993-10 | Housing: PC/ABS Lens: SILICONE are compliance with<br>ISO 10993-5 and ISO 10993-10 |
| Operation Mode | B (2-D), M, CFM, CPA, PW,CW, Tissue Harmonic Image<br>and combine mode | B (2-D), M, Color(CFM), Power(CPA), PW,CW,<br>THI(Tissue Harmonic Image) and combine mode |
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode;<br>2-D/Pulsed Doppler and Triplex 2-D/CD/Pulsed<br>Doppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode;<br>2-D/Pulsed Doppler and Triplex 2-D/Color/Pulsed<br>Doppler image formats; Dual B and Color in real time |
| Display Annotations | Time/date/year; transducer type; power output in %;<br>frames per second; persistence; and compression<br>settings; image depth; patient name and ID; institution<br>name; focal position; TGC curve display; Doppler & M<br>scale in sec; Doppler angle correction cursor; free form<br>annotation anywhere on image; touch controlled;<br>selective or global erase of the display annotations,<br>body markers with transducer annotations | Time/date/year; transducer type; power output in %;<br>frames per second; persistence; and compression<br>settings; image depth; patient name and ID; institution<br>name; focal position; TGC curve display; Doppler & M<br>scale in sec; Doppler angle correction cursor; free form<br>annotation anywhere on image; touch controlled;<br>selective or global erase of the display annotations,<br>body markers with transducer annotations |
| Display Monitor | 11.6" LCD Touch Screen | 13.3" LCD Touch Screen…