Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound technology and image processing techniques without mentioning AI or ML.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is "for diagnostic ultrasound imaging and fluid flow analysis." It explicitly states that it "in no way interprets these images or provides a medical diagnosis of the patient being examined" and that images must be "interpreted by a qualified medical professional," which means it does not directly treat or alleviate a medical condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging" and "It is indicated for diagnostic ultrasound imaging and fluid flow analysis". The "Device Description" also refers to it as a "diagnostic ultrasound device" and mentions its capability for "clinical diagnostic imaging applications."

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like a touch screen display, beam former, and LAN port, indicating it is a physical ultrasound system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the InnoSight Diagnostic Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The InnoSight system is an ultrasound device that uses sound waves to create images of internal structures within the living body.
The intended use and device description clearly state that it is for diagnostic ultrasound imaging of various anatomical sites on patients. This is an in-vivo diagnostic method, not in-vitro.
There is no mention of analyzing biological specimens.

Therefore, the InnoSight Diagnostic Ultrasound System falls under the category of medical imaging devices used for in-vivo diagnosis, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

IYO, IYN, ITX

Device Description

InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" 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 InnoSight diagnostic ultrasound:

64 Channel all digital beam former.
Progressive dynamic receive focusing
Wide band all digital demodulation
Native frequency digital scan converter
InnoSight diagnostic ultrasound can be hand carried for portable use
Remote access image management through LAN port
Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

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)

Not Found

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.

K132690, K162329

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

Regulation Number and Section

§ 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.

Summary

0

December 13, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Qisda Corporation % Mr. Bob Leiker Owner/manager Leiker Regulatory & Quality Consulting 4157 North Del Rav Circle CLOVIS CA 93619

Re: K172056

Trade/Device Name: InnoSight Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: November 7, 2017 Received: November 14, 2017

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

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3

PREMARKET NOTIFICATION [510(k)] Summary

| Company Name: | Qisda Corporation
No.157,Shanying Rd.,Gueishan Dist.,Taoyuan City, Taiwan | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Bob Leiker
Leiker Regulatory & Quality Consulting
4157 North Del Rey Circle in Clovis, CA 93619
Telephone: (925) 556-1302
Fax: (866) 718-3819
E-mail: leiker-requlatory@comcast.net | |
| Device Name: | InnoSight Diagnostic Ultrasound System | |
| Common Name: | Diagnostic Ultrasound Imaging System | |
| Classification Name: | Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology | |
| | Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Diagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX | |
| Registration Number: 3010220244 | | |
| Factory Location: | Qisda Corporation
No.159,Shanying Rd.,Gueishan Dist.,Taoyuan City Taiwan | |

Predicate Device Comparison:

The BenQ UP600 (K132690) and Philips CX50 and Sparq (K162329) are 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.

| Qisda
Product Name
510(k) Number | Predicate Device
BenQ Medical Technology UP600 | Submission Device
InnoSight Diagnostic Doppler Ultrasound | Predicate Device
CX50 and Sparq Diagnostic Ultrasound Systems |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K132690 | Pending | K162329 |
| Qisda | Predicate Device | Submission Device | Predicate Device |
| Indications for Use | This device is a general-purpose ultrasonic imaging
instrument intended for use by a qualified physician
for evaluation of Abdomen; Pediatric; Small Organ
(breast, testes, thyroid); heart soft tissue; Peripheral
Vascular; Musculo-skeletal; Ob/Gyn and Urology. | InnoSight Diagnostic Ultrasound System is intended Philips CX50 and Sparq Diagnostic Ultrasound
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. | Systems are intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic, Intraoperative, Laparoscopic, Fetal,
Abdominal, Pediatric, Small Organ, Adult Cephalic,
Neonatal Cephalic, Trans-vaginal, Musculo-skeletal,
Gynecological, Cardiac Adult, Cardiac Pediatric,
Trans-Esoph. (Cardiac), Intracardiac echo,
Peripheral Vessel, Other (Carotid) |
| Design | Based on 128 channel full digital beam former. | Based on 64 channel full digital beam former. | Based on 128 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 1.5 to 10 MHz. | 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 | Autocorrelation for color processing and FFT for pulse and CW Doppler processing.
It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: |
| | Cine play back capability and Image file archive | § TGC 8 slider, +/- 22.5 dB | * TGC 8 slider |
| | Software upgrade with USB flash drive. | § Depth Range: 1 to 28 cm | * Depth Range: 1 to 30 cm |
| | Digital Scan Converter 1024x768 | § Image sector size: 46 lines to full B (256 lines) | * Digital Scan Converter 1024x768 |
| | TGC 8 slider, +/- 24dB | § Image Sector position: Steering within full maximum | * B orientation flip: L/R invert key |
| | § Depth Range: 3 to 24 cm | § B orientation flip: L/R key with marking on the screen | * B Dynamic range control: Up to 170 dB |
| | § Image sector size: 32 lines to full B (256 lines) | § B Dynamic range control: preset 100 levels | * Image Processing: Smoothing, edge enhancement |
| | § Image Sector position: Steering within full maximum | § Gray Scale Control: 5 levels | * PW/B update: with UPDATE key |
| | § B orientation flip: L/R key with marking on the screen | § Focal Number: 10 focal zone setting | * PW cursor steering: Steer key |
| | § B Dynamic range control: preset 5 curves over 50-90 dB | § B persistence: 10 levels | * Spectrum baseline shift and invert |
| | § Gray Scale Control: 7 Settings | § Image Processing: Smoothing, edge enhancement | * Color ROI setting: trackball and set key to control size and position |
| | § Focal Number: 12 focal zone setting | § PW sweeping speed 1,2,4,8 sec over display. | * Freeze control: Touch freeze key |
| | § B persistence: 30-90% recursive | § PW Wall filter setting: 20 levels | * PW Wall filter setting |
| | § Image Processing: Smoothing, edge enhancement | § PW sample volume: 0.23 to 20 mm | * PW sample volume: 0.8 to 24.6mm |
| | § PW sweeping speed 2,4,8 sec over display. | § PW/B update: with UPDATE key | * Continuously variable steering in 2D, color Doppler, and Doppler modes |
| | § PW Wall filter setting: 15 settings, 0.25 to 20% of | § PW cursor steering: Steer key | * Color Wall Filter setting |
| | PRF | § PW angle correction: - 72,0,72 degree user control | * PW selectable sweep speeds |
| | § PW sample volume: 0.5 to 10mm with 0.5mm step size. | § PW spectrum dynamic range: 8 preset curve over 10-80 dB | * Spectrum normal/invert display around baseline |
| | § PW/B update: with UPDATE key | § Spectrum baseline shift and invert | * High definition zoom |
| | § PW cursor steering: Steer key | § M Process: Peak, Mean | * Cine control: step, play backward, play continuously |
| | § PW angle correction: 0 to 72 degree user control | § Color ROI setting: Touch and drag to control size | Color & B (echo) priority: controls for echo write priority |
| | § PW spectrum dynamic range: 5 preset curve over 15-48 dB | and position
§ Color steering on flat probe: +/- 15 | |
| | § Spectrum baseline shift and invert | § Color Wall Filter: Color wall filter with 20 settings | |
| | § M Process: Peak, Mean | § Color & B priority: C-B priority Key | |
| | § Color ROI setting: trackball and set key to control size and position | § Color Packet size: preset per Exam range from 8 to 11 | |
| | § Color steering on flat probe: +/- 15 | § Zoom factor: Up to 5x | |
| | § Color Wall Filter: Color wall filter with 15 selection, 0.25-20% of PRF | § Freeze control: Touch freeze key | |
| | § Color & B priority: C-B priority soft menu | § Cine control: step, play backward, play continuously | |
| | § Color Packet size: preset per Exam range from 8 to 12
§ Color spatial filter: preset per Exam, horizontal, vertical, off
§ Zoom factor: 1.2, 1.5, 2, 2.5, 3, 4 | | |
| | § Freeze control: Toggling freeze key | | |
| | § Cine control: step, play backward, play continuously | | |
| Qisda | Predicate Device | Submission Device | Predicate 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 | 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 | 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 |
| Patient Contact Materials | 2-37
RTV664+Ultrason S2010 silicon rubber complies
with ISO10993-5 and ISO10993-10 | 2-37
Housing: P1700 and Valox420/ Lens: RTV 664 and
RTV560/ Glue:KE45 are compliance with ISO | 2-37
All patient contact materials of the CX50 Ultrasound
System and transducers are detailed in K123754. |
| Operation Mode | B (2-D), M, CFM,CPA, PW, CW, Tissue Harmonic
Image and combine mode | 10993-5 and ISO 10993-10
B (2-D), M, CFM, CPA, PW,CW, Tissue Harmonic
Image and combine mode | 2D Echo, M-mode, PW, CW, 2D Color, Tissue
Tissue Doppler and Harmonics (Tissue and
Contrast) and Combination modes |
| 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/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/CD/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;
trackball 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;
trackball controlled; selective or global erase of the
display annotations, body markers with transducer
annotations | transducer type and frequency, active clinical
options and optimized presets, display depth, TGC
curve, grayscale, color map, frame rate,
compression map value, color gain, color image
mode, hospital name, and patient demographic
data, Scan plane orientation marker, User selectable
depth scale display, Multiple trackball-driven
annotation arrows, Pre-defined body markers. |
| Display Monitor | 15" LCD color monitor | 11.6" LCD Touch Screen | 15" LCD color monitor (CX50) |
| 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. | Distance; area; Volume; circumference; Heart Rate;
calipers; velocity; Pl, RI, Cardiac, OB/GYN and
Vascular package and QLAB quantification |
| Transducer Types &
Connectors | Convex, Phase array, and Linear array probes;
Multi-port connector connects up to 2 transducers | Convex, Phase array, and Linear array probes;
Single-port connector connect 1 transducer | Convex, Phase array, Linear array, xMATRIX and
CW probes, Single-port connector connect 1
transducer (CX50), Multi-port connector connects up
to 3 transducer (Sparq) |
| Transducer List | * C52

E94
L115
P42 | * C6-2
C9-4v
L12-4
S4-2 | * C6-2
C9-4v
L12-4
S4-2
C5-1
L5-7io
X7-2t
C8-5
C9-3io
C9-3v
C10-3v
D2 cwc
D5 cwc
L10-4lap
L12-3
L12-5
L15-7io
S2-4
S5-1
S7-3t
S8-3
St. Jude Medical ViewFlex Xtra |
| Principle of Operation
Users / Sites | 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.
Hospitals, clinics usage | 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.
Hospitals, clinics usage | 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.
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 | Track 3; MI, TIS, TIC, TIB Derated Ispta:
720mW/cm2 maximum, Mechanical Index: 1.9
Maximum, Thermal Index: 6.0 Maximum |
| Labeling | Operator's Manual, brochure | Operator's Manual, brochure | Operator's Manual, brochure |
| Dimensions / Weight | Dimension: Height 36.1cm Width 36.3cm Depth
18.7cm Weight: 9kg | Dimension: Height 223.2 mm Width 319.6 mm
Depth 31.8 mm Weight: 2.46 kg | Dimension: Height 7.6 cm Width 41.3 cm Length
35.6 mm Weight: 6.17 kg (CX50) |
| Power Requirements | Power requirements: 100 Volts AC, 2.5 Amps 120
Volts AC, 2.1 Amps 230 Volts AC, 1.1 Amps 250
Volts AC, 1 Amps Power Consumption: 180 watts,
max Operating temperature 5-40° C; relative | Power requirements: 115 Volts AC, 1.14 Amps 230
Volts AC, 0.79 Amps Power Consumption: 65 watts,
max Operating temperature 10-40° C; relative
humidity 20-85%; | System/AC adapter 100-240V, 50/60 Hz, 250 VA
System with cart and peripherals 100-240V, 50/60
Hz, 500 VA, max Operating temperature 10-40° C;
relative humidity 15-95%; |
| Peripherals and Accessories | humidity 10-80%;
LAN Picture quality Color Printer, USB flash mobile
drive , S-video output, VGA output | LAN, USB thermal Printer, USB flash mobile drive,
HDMI video output | LAN, B/W and Color Printer, USB flash mobile drive,
SVGA video output |
| 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. | | |
| Appendix I | Premarket Notification 510(k) Summary | Page 4 of 6 | |

4

5

General Device Description:

Appendix I

6

InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" 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 InnoSight diagnostic ultrasound:

64 Channel all digital beam former .
Progressive dynamic receive focusing
Wide band all digital demodulation
Native frequency digital scan converter
InnoSight diagnostic ultrasound can be hand carried for portable use
Remote access image management through LAN port
Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode

Intended 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 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.

Technological Characteristics:

7

| Description of
Transducers | InnoSight Diagnostic Ultrasound System with
C6-2Curved Linear Array 2-6MHz
L12-4Linear Array 4-12MHz
S4-2Phase Array 64 elements 2-4MHz
C9-4vMicro Curved Linear Array 4-9MHz |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, +/- 22.5 dB Depth Range: 1 to 30 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 100 levels over 20-100 dB Gray Scale Control: 4 Settings Focal Number: 10 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 20 settings, 1% to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer key PW angle correction: +/- 72 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 8 preset curve over 15-96 dB Spectrum baseline shift and invert Color ROI setting: Touch and drag to control size and position Color steering on flat probe: +/- 20 Color Wall Filter: Color wall filter with 20 settings, 1% to 20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: Up to 10x Freeze control: Touch freeze key Cine control: step, play backward, play continuously |
| Acoustic
Output | Conform to EN60601-2-37 and AIUM UD2/UD3 requirements for all modes of all probes |

8

SAFETY CONSIDERATIONS:

InnoSight diagnostic ultrasound has been designed to meet the following voluntary and measurement standards:

| Recognition

Number	Regulations No./ Version	Recognition Standard
12-100	NEMA UD 3-2004	Standard for Real Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment
12-105	NEMA UD 2-2004 (R2009)	Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision 3
(Radiology)
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
19-4	AAMI / ANSI 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 (lec 60601-1:2005, Mod). (General II
(ES/EMC))
19-2	AAMI / ANSI / IEC
60601-1-2:2007/(R)2012	Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements And Tests (Edition 3).
(General II (ES/EMC))
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)
(Biocompatibility)