K Number
K132690
Device Name
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2014-02-25

(181 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology features.

No.

The intended use and device description clearly state that it is a "diagnostic ultrasonic imaging instrument" or a "diagnostic doppler ultrasound system", used for "evaluation" and "clinical diagnostic imaging applications," not for therapeutic purposes.

Yes
The "Device Description" explicitly states, "The UP600 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device..." and "capable of producing a resolution intended for clinical diagnostic imaging applications."

No

The device description explicitly states it is a "diagnostic doppler ultrasound system" and a "compact and portable diagnostic ultrasound device" with a "specialized control keyboard and color 15-inch LCD display," indicating it includes hardware components beyond just software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The description clearly states that this is a general-purpose ultrasonic imaging instrument used for imaging various anatomical sites within the human body. It does not involve the analysis of in vitro specimens.

The device is a diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

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

For the E94 Micro Convex Array 4-9MHz Diagnostic Ultrasound Transducer, the new indications are: Trans-rectal, Trans-vaginal, and Other (Ob/GYN).

Product codes

IYN, IYO, ITX

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Abdomen, Cardiac, Small Organ (breast, testes, thvroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, Ob/Gyn, Fetal/QB, Abdominal (GYN & Urology), Transrectal, Transvaginal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician / Hospitals, clinics usage

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)

K121983, K102989, K053435

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

0

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 Corporation
7F., No. 46, Zhou-Z St., Nei-Hu, Taipei 114, Taiwan | | | | FEB 25 2014 |
|----|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|-------------|
| | Factory Location: | Qisda Corporation
159 Shan-ying Road, Gueishan,
Taoyuan 333, Taiwan | | | | |
| | Contact: | Bob Leiker
Leiker Regulatory & Quality Consulting
7263 Cronin Circle
Dublin, CA 94568
Tel: (925) 719-1946    Fax: (866) 718-3819 | | | | |
| 2. | Device Name: | UP600 Diagnostic Doppler Ultrasound System with
C52 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 Name21 CFR SectionProduct Code
Ultrasonic pulsed doppler imaging system892.155090-IYN
Ultrasonic pulsed echo imaging system892.156090-IYO
Diagnostic ultrasonic transducer892.157090-ITX

2. Marketed Devices:

OwnerPredicate Device510(k) Number
BenQ Medical TechnologyUP600K121983
GE HealthcareVoluson iK053435
CGMCOPUS 5000K102989

3. 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.

Premarket Notification

1

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:

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.

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:

..

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.

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.

2

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

510(k) Submission

Submission DevicePredicate DevicePredicate Device
Product NameBenQ Medical Technology UP600CGMC OPUS 5000GE Voluson I
510(k) NumberPendingK102989K102989
Indications for UseThis 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.Intended for use of evaluating
Abdomen; Pediatric; Small Organ
(breast, testes, thyroid); heart soft
tissue; Peripheral Vascular, Musculo
-skeletal and Urology.Intended for use of evaluating
Abdomen; Pediatric; Small Organ
(breast, testes, thyroid); heart soft
tissue; Peripheral Vascular,
Musculo -skeletal and Urology.
DesignBased on 128 channel full digital beam
former.Based on 64 channel full digital
beam former.Based on a 128 channel full digital
beam former.
Safety ComplianceIEC601-1 International Electrotechnical
Comission; Medical Electrical Equipment
IEC60601-2 International
Electrotechnical Comission;
Electromagnetic CompatibilityIEC601-1 International
Electrotechnical Comission; Medical
Electrical Equipment
IEC60601-2 International
Electrotechnical Comission;
Electromagnetic CompatibilityIEC 60601-1 Electrical medical
equipment,
IEC 60601-1-1 Electrical medical
equipment
IEC 60601-1-2 Electromagnetic
compatibility
Patient Contact
MaterialsRTV664+Ultrason S2010 silicon rubber
complies with ISO10993-5RTV664+Ultrason S2010 silicon
rubber complies with ISO10993-5GE RTV630A/B silicon rubber
complies with ISO 10993-5
Operation ModeB (2-D), M, CFM,CPA, PW, CW, Tissue
Harmonic Image and combine modeB, M, CFM, Power Doppler, PW,
CW, Tissue Harmonic Image and
combine modeB-Mode (2D). M-Mode, M-Color-
Mode, Color Flow Mode, Power
Doppler Imaging, PW Doppler,
Volume Mode (3D/4D):, 3D Static.
3D with Color Flow, 4D Real-Time
Display ModesSingle 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 timeSingle 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 timeReal-Time Triplex Mode, Multi-
image (split, quad). Colorized
Image. Time line display.
Independent Dual B/PW Display,
Display Monitor15" LCD color monitor15" LCD color monitorHigh-Resolution 15-inch TFT LCD
Screen
MeasurementsDistance; 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.Obstetrics, Gynecology,
Abdominal. Small-Parts, Vascular,
Pediatrics, Urology. Ortho,
Cardiology
Transducer Types &
ConnectorsConvex and Micro-convex (endo-cavity),
Phase array, and Linear array probes.
Multi-port connector connects up to 2
transducersConvex, Phase array, Linear array,
and Transvaginal Micro-Curved
Linear probes, Multi-port connector
connects up to 2 transducers.Convex Array
· Linear Array
• Volume probes '4D' Convex
Array
· Volume probes '4D' Linear Array
Principle of OperationApplying high voltage burst to the
Piezoelectric material in the transducer
and detect the reflected echo to construct
the 2-D B-mode, Doppler color, and
Doppler spectrum image for diagnostic
purpose.Applying high voltage burst to the
Piezoelectric material in the
transducer and detect the reflected
echo to construct the 2-D B-mode,
Doppler color, Doppler spectrum
image for diagnostic purpose.Applying high voltage burst to the
Piezoelectric material in the
transducer and detect the
reflected echo to construct the 2-D
B-mode, Doppler color, Doppler
spectrum image for diagnostic
purpose
Users / SitesHospitals, clinics usageHospitals, clinics usageHospitals, clinics usage
Acoustic OutputTrack 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 maxTrack 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 maxTrack 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
LabelingOperator's Manual, brochureOperator's Manual, brochureOperator's Manual, brochure
Dimensions / WeightDimension:
Height 36.1cm
Width 36.3cm
Depth 18.7cm
Weight: 9kgDimensions
Height 40 cm
Width 40 cm
Depth 20 cm
Weight: 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 RequirementsPower 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
humidity 10-80%;Power requirements:
100 Volts AC, 3.3 Amps
120 Volts AC. 2.7 Amps
230 Volts AC, 1.4 Amps
250 Volts AC, 1.3 Amps
Power Consumption 200 watts, max
Operating temperature 15-40° C;
relative humidity 10-90%;Electrical Power
· Voltage: 100 - 240 V
· Frequency: 50/60 Hz

Premarket Notification

3

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.

4

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 2-5MHzL115 Linear Array 5-11MHz
P42 Phased Array 80 elements 2-4MHzE94 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

6

DEPARTMENT OF HEALTH AND HUMAN SERVICESForm Approved OMB No 0910-0120
Food and Drug AdministrationExpiration Date January 31, 2017
Indications for UseSee PRA Statement on last page

510(k) Number (if known)

್ನೂ

K132690

Device Name UP600 Diagnostic Doppler Ultrasound System

Indications for Use (Describe)

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.

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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
(Amplitude)
DopplerOther*
CombinedTissue
Harmonic
Imaging
General
(Track 1 Only)Specific
(Tracks 1 & 3)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalPPPPPNote 1P
AbdominalPPPPPNote 1P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPNote 1P
Small Organ(1) (Breast, Thyroid,
Testes)PPPPPNote 1P
Neonatal CephalicPPPPPPNote 1P
Adult CephalicPPPPPPNote 1P
Trans-rectalNNNNNNote 1N
Trans-vaginalNNNNNNote 1N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)PPPPPNote 1P
Musculo-skeletal (Superficial)PPPPPNote 1P
Intravascular
Other (Ob/GYN)PPPPPNote 1P
CardiacCardiac AdultPPPPPPNote 1P
Cardiac PediatricPPPPPPNote 1P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselPPPPPNote 1P

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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor DopplerPower (Amplitude) DopplerOther* CombinedTissue Harmonic Imaging
OphthalmicOphthalmic
Fetal Imaging & OtherFetalPPPPPNote 1P
AbdominalPPPPPNote 1P
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)PPPPPNote 1P
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VesselPeripheral 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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BM PWDCWDColor
DopplerPower
(Amplitude)
DopplerOther*
CombinedTissue
Harmonic
Imaging
OphthalmicOphthalmic
Fetal Imaging &
OtherFetal
AbdominalPPPPPNote 1P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ¹¹ (Breast, Thyroid,
Testes)
Neonatal CephalicPPPPPNote 1P
Adult CephalicPPPPPNote 1P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Ob/GYN)
CardiacCardiac AdultPPPPPNote 1P
Cardiac PediatricPPPPPNote 1P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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

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

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerPower
(Amplitude)
DopplerOther*
CombinedTissue
Harmonic
Imaging
OphthalmicOphthalmic
Fetal Imaging &
OtherFetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ1 (Breast, Thyroid,
Testes)
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNote 1N
Trans-vaginalNNNNNNote 1N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Ob/GYN)NNNNNNote 1N
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral 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)