The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, and Ob/Gyn.

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/QB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

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.

The device is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Abdomen, Cardlac, Small Organ (breast, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal, Trans-vaginal, Urology.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Description

The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control kevboard and color 15-inch LCD display. The digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows system integration to a variety of upgrade-able options and features.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System. This document does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format expected for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this specific document, as it predates the widespread regulatory expectations for AI/ML device evaluations.

Here's a breakdown of what can be extracted, along with explanations for what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria (e.g., specific sensitivity, specificity, or image quality metrics) or report performance against such criteria. Instead, it relies on demonstrating comparable technological characteristics and intended uses to legally marketed predicate devices. The "performance" aspect is implicitly shown by comparison to these predicate devices rather than through specific quantitative metrics presented for the UP600 itself.

Category	Acceptance Criteria (Not explicitly stated as such, but inferred from comparison)	Reported Device Performance (as presented in the document)
Compliance to Standards	Meeting relevant safety standards.	UP600: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1. (Also explicitly states compliance with IEC601-1 and IEC60601-2 under safety compliance in comparison table).
Indications for Use	Comparable to predicate devices.	UP600: General-purpose ultrasonic imaging instrument for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Trans-rectal and Trans-vaginal. (Matches or expands upon predicate devices, with specific modes enabled for each application per transducer, as shown in the "Indications for Use" tables for each transducer).
Device Design	Similar architecture to predicate devices allowing for comparable functionality.	UP600: 128 Channel all digital beam former. Compact and portable. User interface includes specialized control keyboard and color 15-inch LCD display. Progressive dynamic receive focusing. Wide band all digital demodulation. Native resolution digital scan converter. Features: 2D 8-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW. Supports 2D/M-mode, 2D/Pulsed Doppler, Triplex 2-D/CD/Pulsed Doppler, Dual B and Color in real time. (Similar to GE Voluson I (128 channel) and more advanced than CGMC OPUS 5000 (64 channel)).
Measurement Functions	Comprehensive measurement capabilities.	UP600: Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascular package. (Comparable to predicate devices).
Acoustic Output	Below applicable FDA limits.	UP600: 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. (Identical to predicate devices).
Patient Contact Materials	Biocompatibility.	UP600: RTV664+Ultrason S2010 silicon rubber complies with ISO10993-5. (Identical to CGMC OPUS 5000, different from GE RTV630A/B silicon rubber but also complying with ISO 10993-5).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As a premarket notification for a general ultrasound system based on substantial equivalence, the submission primarily focuses on technical specifications, safety standards, and comparison to existing devices rather than clinical study data with specific test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No specific clinical test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No specific clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device submission. The UP600 is a diagnostic ultrasound system, a hardware device, and does not incorporate AI/ML functionality that would assist human readers in image interpretation. Therefore, there is no "AI vs without AI assistance" comparison.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation of an algorithm was not performed, nor is it applicable. The UP600 is a diagnostic ultrasound system, not an algorithm, and is intended for use by a qualified physician (human-in-the-loop).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. No specific ground truth for performance evaluation is mentioned, as the focus is on substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. This device is a hardware system, not an AI/ML algorithm that would typically have a training set.

9. How the ground truth for the training set was established

This information is not provided in the document. Not applicable for this hardware device.

Summary of the Study (or lack thereof, in the context of AI/ML evaluation):

The BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System's acceptance was based on a demonstration of substantial equivalence to legally marketed predicate devices (BenQ Medical Technology UP600 K121983, GE Healthcare Voluson i K053435, and CGMC OPUS 5000 K102989). This is the primary "study" or justification presented in the 510(k) summary.

The document highlights the following to support substantial equivalence:

Comparable Indications for Use: The UP600 and its transducers are intended for the same clinical applications as the predicate devices.
Similar Technological Characteristics: The UP600 shares core operational principles (applying high voltage burst to piezoelectric material, detecting reflected echoes, constructing 2D B-mode, Doppler color, and Doppler spectrum images) and many features (display modes, measurements, transducer types) with the predicate devices. Some features, like the 128-channel digital beam former, are even identical to one predicate (GE Voluson I) and an improvement over another (CGMC OPUS 5000).
Compliance with Safety Standards: The device meets recognized national and international safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
Equivalent Acoustic Output: The acoustic output levels are identical to the predicate devices and stated to be below applicable FDA limits ("Track 3; MI, TIS, TIC, TIB. Derated Ispta: 720mW/cm2 maximum," etc.).
Biocompatible Patient Contact Materials: Materials used for patient contact are compliant with ISO10993-5 (a standard for biological evaluation of medical devices).

The 510(k) summary concludes that "The UP600 is substantially equivalent in safety and effectiveness to the predicate systems." This implies that by meeting the technical and safety specifications and having comparable intended uses to already cleared devices, it is deemed safe and effective without the need for extensive clinical performance studies that would typically involve test sets, expert ground truth, or AI-specific evaluations.

Summary

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PREMARKET NOTIFICATION [510(k)] Summary

This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).

1.	Company Name:	BenQ Medical Technology Corporation7F., No. 46, Zhou-Z St., Nei-Hu, Taipei 114, Taiwan
	Factory Location:	Qisda Corporation159 Shan-ying Road, Gueishan,Taoyuan 333, Taiwan
	Contact:	Bob LeikerLeiker Regulatory & Quality Consulting7263 Cronin CircleDublin, CA 94568Tel: (925) 719-1946 Fax: (866) 718-3819
2.	Device Name:	UP600 Diagnostic Doppler Ultrasound System withC52 Curved Linear Array 2-5MHz,L115 Linear Array 5-11MHz,P42 Phase Array 80 elements 2-4MHz,E94 Micro Convex Array 4-9MHz
		Common/Usual Name: Diagnostic Ultrasound System with Accessories

Classification: Regulatory Class: II Review Category: Tier II

Classification Name	21 CFR Section	Product Code
Ultrasonic pulsed doppler imaging system	892.1550	90-IYN
Ultrasonic pulsed echo imaging system	892.1560	90-IYO
Diagnostic ultrasonic transducer	892.1570	90-ITX

2. Marketed Devices:

Owner	Predicate Device	510(k) Number
BenQ Medical Technology	UP600	K121983
GE Healthcare	Voluson i	K053435
CGMC	OPUS 5000	K102989

3. Device Description:

Premarket Notification

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The major features of the UP600:

128 Channel all digital beam former Progressive dynamic receive focusing Wide band all digital demodulation Native resolution digital scan converter Hand carried for portable use USB2.0 flash drive for image transport and software upgrade Supports 2D 8-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.

Intended Use:

Technological Characteristics:

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.

Measurements:

Distance: area; circumference; calipers; velocity, Pl, Rl. OB, Urology, Cardiac 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 purposes.

The UP600 has been designed to meet the following product safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.

4. Indications for Use:

Comparison to Predicate Device:

The UP600 is of comparable type and substantially equivalent to both the GE Healthcare Voluson i, and the CGMC OPUS 5000. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations.

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BenQ Medical Technology UP600 Diagnostic Doppler Ultrasound System
--------------------------------------------------------------------

510(k) Submission

	Submission Device	Predicate Device	Predicate Device
Product Name	BenQ Medical Technology UP600	CGMC OPUS 5000	GE Voluson I
510(k) Number	Pending	K102989	K102989
Indications for Use	This device is a general-purposeultrasonic imaging instrument intendedfor use by a qualified physician forevaluation of Abdomen; Pediatric; SmallOrgan (breast, testes, thyroid); heart softtissue; Peripheral Vascular; Musculo-skeletal; Ob/Gyn and Urology.	Intended for use of evaluatingAbdomen; Pediatric; Small Organ(breast, testes, thyroid); heart softtissue; Peripheral Vascular, Musculo-skeletal and Urology.	Intended for use of evaluatingAbdomen; Pediatric; Small Organ(breast, testes, thyroid); heart softtissue; Peripheral Vascular,Musculo -skeletal and Urology.
Design	Based on 128 channel full digital beamformer.	Based on 64 channel full digitalbeam former.	Based on a 128 channel full digitalbeam former.
Safety Compliance	IEC601-1 International ElectrotechnicalComission; Medical Electrical EquipmentIEC60601-2 InternationalElectrotechnical Comission;Electromagnetic Compatibility	IEC601-1 InternationalElectrotechnical Comission; MedicalElectrical EquipmentIEC60601-2 InternationalElectrotechnical Comission;Electromagnetic Compatibility	IEC 60601-1 Electrical medicalequipment,IEC 60601-1-1 Electrical medicalequipmentIEC 60601-1-2 Electromagneticcompatibility
Patient ContactMaterials	RTV664+Ultrason S2010 silicon rubbercomplies with ISO10993-5	RTV664+Ultrason S2010 siliconrubber complies with ISO10993-5	GE RTV630A/B silicon rubbercomplies with ISO 10993-5
Operation Mode	B (2-D), M, CFM,CPA, PW, CW, TissueHarmonic Image and combine mode	B, M, CFM, Power Doppler, PW,CW, Tissue Harmonic Image andcombine mode	B-Mode (2D). M-Mode, M-Color-Mode, Color Flow Mode, PowerDoppler Imaging, PW Doppler,Volume Mode (3D/4D):, 3D Static.3D with Color Flow, 4D Real-Time
Display Modes	Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler andTriplex 2-D/CD/Pulsed Doppler imageformats;Dual B and Color in real time	Single and dual 2-D; Display ofDuplex 2-D/M-mode; 2-D/PulsedDoppler and Triplex 2-D/CD/PulsedDoppler image formats:Dual B and Color in real time	Real-Time Triplex Mode, Multi-image (split, quad). ColorizedImage. Time line display.Independent Dual B/PW Display,
Display Monitor	15" LCD color monitor	15" LCD color monitor	High-Resolution 15-inch TFT LCDScreen
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/GYNand Vascular package.	Obstetrics, Gynecology,Abdominal. Small-Parts, Vascular,Pediatrics, Urology. Ortho,Cardiology
Transducer Types &Connectors	Convex and Micro-convex (endo-cavity),Phase array, and Linear array probes.Multi-port connector connects up to 2transducers	Convex, Phase array, Linear array,and Transvaginal Micro-CurvedLinear probes, Multi-port connectorconnects up to 2 transducers.	Convex Array· Linear Array• Volume probes '4D' ConvexArray· Volume probes '4D' Linear Array
Principle of Operation	Applying high voltage burst to thePiezoelectric material in the transducerand detect the reflected echo to constructthe 2-D B-mode, Doppler color, andDoppler spectrum image for diagnosticpurpose.	Applying high voltage burst to thePiezoelectric material in thetransducer and detect the reflectedecho to construct the 2-D B-mode,Doppler color, Doppler spectrumimage for diagnostic purpose.	Applying high voltage burst to thePiezoelectric material in thetransducer and detect thereflected echo to construct the 2-DB-mode, Doppler color, Dopplerspectrum image for diagnosticpurpose
Users / Sites	Hospitals, clinics usage	Hospitals, clinics usage	Hospitals, clinics usage
Acoustic Output	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm2 maximum,TIS/TIB/TIC:0.1-4.0 Range, MechanicalIndex: 1.9 Maximum, or Derated Isppa:190 W/cm² max	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm2maximum, TIS/TIB/TIC: 0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa: 190W/cm2 max	Track 3: MI, TIS, TIC, TIBDerated Ispta: 720mW/cm2maximum, TIS/TIB/TIC:0.1-4.0Range, Mechanical Index: 1.9Maximum, or Derated Isppa: 190W/cm2 max
Labeling	Operator's Manual, brochure	Operator's Manual, brochure	Operator's Manual, brochure
Dimensions / Weight	Dimension:Height 36.1cmWidth 36.3cmDepth 18.7cmWeight: 9kg	DimensionsHeight 40 cmWidth 40 cmDepth 20 cmWeight: 11kg	· Height: 59 mm (2.3 in)• Width: 358 mm (14.2 in)· Depth: 313 mm (12.4 in)· Weight (no peripherals):11 lb (5kg)
Power Requirements	Power requirements:100 Volts AC, 2.5 Amps120 Volts AC, 2.1 Amps230 Volts AC, 1.1 Amps250 Volts AC, 1 AmpsPower Consumption: 180 watts, maxOperating temperature 5-40° C; relativehumidity 10-80%;	Power requirements:100 Volts AC, 3.3 Amps120 Volts AC. 2.7 Amps230 Volts AC, 1.4 Amps250 Volts AC, 1.3 AmpsPower Consumption 200 watts, maxOperating temperature 15-40° C;relative humidity 10-90%;	Electrical Power· Voltage: 100 - 240 V· Frequency: 50/60 Hz

Premarket Notification

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K132690
Page 4 of 4
510(k) Submission

5. Conclusion:

The UP600 is substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.

End of 510(k) Summary.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized symbol resembling three overlapping waves or stripes, which is the department's emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

BenQ Medical Technology Corporation/Qisda Corporation % Mr. Bob Leiker Leiker Regulatory & Quality Consulting (LRQC) 7263 Cronin Circle DUBLIN CA 94568

Re: K132690

Trade/Device Name: UP600 Diagnostic Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 28, 2014 Received: January 30, 2014

Dear Mr. Leiker:

We have reviewed vour 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.

This determination of substantial equivalence applies to the following transducers intended for use with the UP600 Diagnostic Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

C52 Curved Linear Array 2-5MHz	L115 Linear Array 5-11MHz
P42 Phased Array 80 elements 2-4MHz	E94 Micro Convex Array 4-9MHz

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.

{5}------------------------------------------------

Page 2-Mr. Leiker

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved OMB No 0910-0120
Food and Drug Administration	Expiration Date January 31, 2017
Indications for Use	See PRA Statement on last page

510(k) Number (if known)

್ನೂ

K132690

Device Name UP600 Diagnostic Doppler Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as epplicable)

[X] Prescription Use (Part 21 CFR 801 Subpan D)

Over-The-Counter Use (21 CFR 801 Subpart Ci

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Rachological Health (CDRH) (Signature) Carpora

Smh. 7)

FORM FDA 3881 (1/14)

• S.A.E. 10W-30 (1)

{7}------------------------------------------------

System: UP600 Diagnostic Doppler Ultrasound System Diagnostic Ultrasound Pulsed Echo System 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
		B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	TissueHarmonicImaging
General(Track 1 Only)	Specific(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	Note 1	P
	Abdominal	P	P	P		P	P	Note 1	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	P
	Small Organ(1) (Breast, Thyroid,Testes)	P	P	P		P	P	Note 1	P
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	P
	Adult Cephalic	P	P	P	P	P	P	Note 1	P
	Trans-rectal	N	N	N		N	N	Note 1	N
	Trans-vaginal	N	N	N		N	N	Note 1	N
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	Note 1	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	Note 1	P
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	P
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	P
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	P
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	Note 1	P

N = new indication; P = previously cleared by FDAE = added under this appendix

Note 1: Combined includes: BIM; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Prescription Use_ ど (Pari 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 (ODDF)

{8}------------------------------------------------

System: UP600 Diagnostic Doppler Ultrasound System C52 Curved Linear Array 2-5MHz 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)	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Other* Combined	Tissue Harmonic Imaging
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	P	P	P		P	P	Note 1	P
	Abdominal	P	P	P		P	P	Note 1	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ 1 (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)	P	P	P		P	P	Note 1	P
Cardiac	Cardiac Adult
	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

N = new indication; P = previously cleared by FDA E = added under this appendix Note 1: Combined includes: BM: BIPWD; BIColor Doppler: BIPower Doppler/PWD and BiPower Doppler/PWD

Prescription Use N (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 (0)DE)

{9}------------------------------------------------

UP600 Diagnostic Doppler Ultrasound System System: L115 Linear Array 5-11MHz Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation General Specific B M |PWD CWD Color Power Other* Tissue (Track 1 Only) (Tracks 1 & 3) Doppler Combined Harmonic (Amplitude) Doppler Imaging Ophthalmic Ophthalmic Fetal Imaging & |Fetal Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric Small Organ (1) (Breast, Thyroid, P P P P P ာ Note 1 Testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) P P P P P Note 1 P P P P P Musculo-skeletal (Superficial) p Note 1 P Intravascular Other (Ob/GYN) Cardiac Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) . Intra-cardiac Other (Specify) P P Peripheral Peripheral vessel p P P p Note 1 Vessel Other (Specify)

N = new indication; P = previously cleared by FDA E = added under this appendix Note 1: Combined includes: BM: B/PWD; B/Color Doppler; B/Power Doppler/PWD and B/Power Doppler/PWD

Prescription Use 1 (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 Fivaliation (ODD)

{10}------------------------------------------------

System: UP600 Diagnostic Doppler Ultrasound System P42 Phased Array 80 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)	B	M PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	P	P	P	P	P	Note 1	P
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ¹¹ (Breast, Thyroid,Testes)
	Neonatal Cephalic	P	P	P	P	P	Note 1	P
	Adult Cephalic	P	P	P	P	P	Note 1	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	P
	Cardiac Pediatric	P	P	P	P	P	Note 1	P
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = now indication; P = previously cleared by FDA E = added under this appondix Note 1: Combined includes: BM: BIPWD: BIColor Doppler: BIPower Doppler/PWD and BiPower Doppter/PWD

Prescription Use_ バ (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 (DDDI)

{11}------------------------------------------------

UP600 Diagnostic Doppler Ultrasound System System: E94 Micro Convex Array 4-9MHz Diagnostic Ultrasound Transducer

ﺎ

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)	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	Other*Combined	TissueHarmonicImaging
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ1 (Breast, Thyroid,Testes)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	Note 1	N
	Trans-vaginal	N	N	N		N	N	Note 1	N
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)	N	N	N		N	N	Note 1	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

Note 1: Combined includes: BM: BIPWD: BlColor Doppler: BlColor Doppler/PVD and BiPower Doppler/PWD

Prescription Use_ ﺮ ﺍﻟﻤﺮﺍ (Part 2) 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)

Regulation Number and Section

§ 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.