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K Number
K042326
Device Name
ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
Manufacturer
UltraSonix Medical Corporation
Date Cleared
2004-09-16

(20 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.
Device Description
The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays. These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.
More Information

K020630, K002003, K973767

K020630,K002003,K973767

No
The document describes standard ultrasound imaging and processing capabilities without mentioning AI or ML.

No
The device is described as an "Ultrasound Scanner" intended for "diagnosis and evaluation of soft tissues" and generating "images." These are characteristics of a diagnostic device, not a therapeutic one.

Yes
The "Device Description" explicitly states, "The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system." The "Intended Use / Indications for Use" section also states the device aids "in the diagnosis and evaluation of soft tissues."

No

The device description explicitly mentions "hardware" and "enclosure," indicating it is a physical ultrasound system, not solely 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, including blood, urine, and tissue, taken from the human body to help diagnose diseases or other conditions. They perform tests outside of the body.
  • Device Function: The Ergosonix and Modulo Ultrasound Scanners use ultrasound technology to generate images of internal structures within the body. They are used for diagnostic imaging, not for testing biological samples.
  • Intended Use: The intended use clearly states the device is used to "aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies." This is consistent with diagnostic imaging, not in vitro testing.

Therefore, the device described is a diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images.

The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays.

These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

Mentions image processing

The system can generate real-time compound images and harmonic images.
Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Soft tissues, abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physician

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)

K020630, K002003, K973767

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

SEP 1 6 2004 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound

This summary of safety and effectiveness is provided as part of this Premarket Notification in rnio Gammery the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary.

1.0 Submitter Information

1.1 Submitter

Ultrasonix Medical Corporation 310-3480 Gilmore Way Burnaby, British Columbia Canada V5G 4Y1 (t) 604-437-9500 (f) 604-437-9502

1.2 Contact

lulia Nuca, Quality Assurance (t) 604-437-9500 x 112 (f) 604-437-9502 (e) iulia@ultrasonix.com

1.3 Date Prepared

August, 2004

2.0 Device Name

2.1 Common Name

Ultrasound Imaging System

2.2 Proprietary Name

Ergosonix Ultrasound Scanner Modulo Ultrasound Scanner

2.3 Classification Name

FR NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

1

2.4 Classification

Class Ila

2.5 Predicate Device:

Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767)

2.6 Reason for submission:

Clearance request for new transducers, new applications and a new mode

Transducers:Applications:
PA4-2cardiac
PA3-2interventional
PA7-4intraoperative
L9-4transcranial
L12-5transesophagea
L12-5W
C5-1 60
C5-1 40
ER7
EC9-5
MC7
C7-4
L15-8
T7-4
3DEC9-5
3DC5-1
CC5-1
IOT7-4
IOJ7-4

lmaging mode:

CW Doppler

Name change request

"Ultrasonix Ergosonix 500 Ultrasound Scanner", changed to "Ergosonix Ultrasound Scanner"

New product clearance

"MODULO Ultrasound Scanner"

2

2.7 Device description

The Ergosonix Ultrasound Scanner is a highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed and CW Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images.

The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays.

These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

Frequency Range2-15MHz
Transducer typesLinear array
Curved array
Intracavity array
Phased array

3

The Egosonix and Modulo Ultrasound Scanners are designed to comply with the following standards:

EN 60601-1European Norm, Medical Electrical Equipment
UL 2601-1Underwriters Laboratories Standards, Medical
Electrical Equipment
C22-2 No 601-1Canadian Standards Association, Medical
Electrical Equipment
EM 60601-1-1-2European Norm, Collateral Standard,
Electromagnetic Compatibility
IEC 60601-2-37Particular requirements for the safety of
ultrasonic medical diagnostic equipment
AIUMAcoustic Output Labeling Standard for Diagnostic
Ultrasound Equipment - Jan 1998
AIUMStandard for Real-Time Display of Thermal and
Mechanical Acoustic Output Indices

3.0 Summary of Intended Uses

The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

4.0 Comparison to Predicate Device

The Ergosonix and Modulo Ultrasound Scanners are substantially equivalent to the predicate devices with respect to intended use/indications for use, principles of operation and technological characteristics.

5.0 Technological characteristics

The technological characteristics are substantially similar to that of the predicates. The device operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sounds waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible.

The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode.

4

The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain sliders, depth control, base control and angling, among others.

6.0 Safety considerations

As track 3 ultrasound devices, the Ergosonix and Modulo Ultrasound Scanners are designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD-3.

With respect to limits on acoustic outputs, the Ergosonix and Modulo Ultrasound Scanners comply with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Ergosonix and Modulo Ultrasound Scanners are designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601-2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

The devices' acoustic output limits are:

ISPTA (d)720mW/cm2
TIS/TIB/TIC0.1 - 4.0 (Range)
Mechanical Index (MI)1.9 (Maximum)
ISPPA (d)0 - 700W/cm2 (Range)

The limits are the same as predicate Track 3 devices.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms extending upwards, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Ms. Iulia Nuca Quality Assurance Ultrasonix Medical Corp. 310-3480 Gilmore Way Burnaby, BC, V5G 4YI . . CANADA

Re: K042326

Trade Name: Ergosonix / Modulo Ultrasound Scanners Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic trasducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: August 25, 2004 Received: August 27, 2004

Dear Ms. Nuca:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bour 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). You may, therefore, market the device, subject to I edelul I ood, Drog, and sions of the Act. The general controls provisions of the Act include the general connents provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Ergosonix / Modulo Ultrasound Scanners, as described in your premarket notification:

Transducer Model Number

C5-1 40 convex 1/5MHz 40mm radius transducer C5-1 60 convex 1/5MHz 60mm radius transducer

6

L12-5 linear 5/12MHz 38mm transducer L12-5W linear 5/12MHz 50mm transducer L9-4 linear 4/9MHz 38mm transducer PA3-2 phased array 2/3MHz transducer PA4-2 phased array 2/4MHz transducer PA3-2 phased array 2/4MHz transducer . PA7-4 phased array 4/7MHz transducer ER7 biplane endocavity 5/9MHz transducer EC9-5microconvex endocavity 5/9MHz 10mm radius transducer MC7 microconvex 5/9MHz 10mm radius transducer L15-8 linear 8/15MHz 29mm transducer C7-4 convex 4/7MHz 40mm radius transducer CC5-1 microconvex 1/5MHz 15mm radius transducer T7-4 TEE phased 4/7MHz transducer 3DC5-1 motorized convex 1/5MHz 40mm radius transducer 3DEC9-5 motorized microconvex 5/9MHz 10mm radius transducer IOT7-4 convex 4/7MHz 40mm radius intraoperational transducer IOJ7-4 linear 4/7MHz 38mm radius intraoperational transducer

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may or below 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 or uny 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N Fat 80 77 tucemes (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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

7

Page 3 - Ms. Nuca

Enclosure(s)

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I 27 Imaling of succion for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please rryou destre specific at (301) 594-4591. Additionally, for questions on the contact the Office of Compilanour device, please contact the Office of Compliance at (301) 594promonon and advertising or Joulation entitled, "Misbranding by reference to premarket 4059. Also, please now the regaral information on your responsibilities under the houthcation (21 Orient and overy) ion of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at t (301) 594-1212.

Sincerely yours,

David R. Segerson

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

8

Prescription Use (Per 221 CFR 801.109)

Ergosonix Ultrasound Scanner Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalPPPPPPP (*1)P (*2)
AbdominalPPPNPPPP (*1)P (*2)
Intraoperative (specify)NNNNNNN (*1)N (*2)
Intraoperative NeurologicalNNNNNNN (*1)N (*2)
PediatricPPPNPPPP (*1)P (*2)
Small Organ (specify)PPPPPPP (*1)P (*2)
Neonatal CephalicPPPPPPP (*1)P (*2)
Adult CephalicPPPPPPP (*1)P (*2)
CardiacNNNNNNNN (*1)N (*2)
TransesophagealNNNNNNNN (*1)N (*2)
TransrectalPPPPPPP (*1)P (*2)
TransvaginalPPPPPPP (*1)P (*2)
Transurethral
Intravascular
Peripheral VascularPPPPPPP (*1)P (*2)
LeparoscopicP (*1)P (*2)
MSK ConventionalPPPPPPP (*1)P (*2)
MSK SuperficialPPPPPPP (*1)P (*2)
Other (specify) (*3)NNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 'r B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFMCWD, B/CFMCWD, B/DPD/CWD
    B/WD, B/C/WD, B/CFM/PWD, B/AD/PWD, B/CFMCND, B/CF/C/P/D/
  • 1 BIM, BIPWD, B/OVD, B/OHD, B/O/ M/X WB, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF WEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

9

MODULO Ultrasound Scanner

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalPPPPPPP (*1)P (*2)
AbdominalPPPNPPPP (*1)P (*2)
Intraoperative (specify)NNNNNNN (*1)N (*2)
Intraoperative NeurologicalNNNNNNN (*1)N (*2)
PediatricPPPNPPPP (*1)P (*2)
Small Organ (specify)PPPPPPP (*1)P (*2)
Neonatal CephalicPPPPPPP (*1)P (*2)
Adult CephalicPPPPPPP (*1)P (*2)
CardiacNNNNNNN (*1)N (*2)
TransesophagealNNNNNNN (*1)N (*2)
TransrectalPPPPPPP (*1)P (*2)
TransvaginalPPPPPPP (*1)P (*2)
Transurethral
Intravascular
Peripheral VascularPPPPPPP (*1)P (*2)
Leparoscopic
MSK ConventionalPPPPPPP (*1)P (*2)
MSK SuperficialPPPPPPP (*1)P (*2)
Other (specify) (*3)NNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/D/PWD, B/DPD/PWD, B/CFM/CWD, B/D/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (Division of General

510(k) Nu

10

C5-1 40 convex 1/5MHz 40mm radius transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ØDE)

ion (ODE)
David A. Seymour

vision Sian-Off Division of Reproduc and Radiological De

11

C5-1 60 convex 1/5MHz 60mm radius transducer
----------------------------------------------

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 BM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalue

Evaluation (ODE)
Daniel A. Symm

and 1 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 /

12

L12-5 linear 5/12MHz 38mm transducer

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

"1 BM, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluati

uation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042326

13

L12-5W linear 5/12MHz 50mm transducer

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalua

David h. Seymm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042326
510(k) Number

14

L9-4 linear 4/9MHz 38mm transducer

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD ﮩ

  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)
    PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

ion(ODE)
David R. Syverson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042326
510(k) Number

15

PA3-2 phased array 2/3MHz transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNNN (*1)N (*2)
Small Organ (specify)
Neonatal CephalicNNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNNN (*1)N (*2)
CardiacNNNNNNNN (*1)N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)NNNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

^1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

uation (ODE)
David A. Sypm
Division Sign Off

(Division Sign-O Division of Reproducti and Radiological Dev E 1 011-1 11,

16

PA4-2 phased array 2/4MHz transducer

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNNN (*1)N (*2)
Small Organ (specify)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
CardiacNNNNNNNN (*1)N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)NNNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD, B/DPD/CWD 、
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

valuation (ODE)
David R. Segerson
(Division Sign-Off)

Division of Reproductive, and Radiological Devic

17

PA3-2 phased array 2/4MHz transducer

Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
CardiacNNNNNNNN (*1)N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)NNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD で
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (

David R. Lysem

(Division Sign-Off) Division of Reproductive, and Radiological Devices

18

Prescription Use (Per 221 CFR 801.109)

PA7-4 phased array 4/7MHz transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNNN (*1)N (*2)
Small Organ (specify)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
CardiacNNNNNNNN (*1)N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)NNNNNNN (*1)N (*2)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)
  • *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation {

tion (QDE)

(Division Sign-Off)

(Division Sign-Off, Division of Reproductive, and Radiological Devices

19

ER7 biplane endocavity 5/9MHz transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNNN (*1)N (*2)
TransvaginalNNNNNNN (*1)N (*2)
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 B/M, B/PWD, B/C/ND, B/CFM/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lygass

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices SAHAR

inal

20

EC9-5 microconvex endocavity 5/9MHz 10mm radius transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNNN (*1)N (*2)
TransvaginalNNNNNNN (*1)N (*2)
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Eva

ice Evaluation (ODE)
David R. Severson
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number

21

MC7 microconvex 5/9MHz 10mm radius transducer
Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

*1 BIM, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

David A. Bergman

(Division Sign-Off) Division of Reproductive, Abdo isdiological Devices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

22

L15-8 linear 8/15MHz 29mm transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor Velocity ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) Division of Reproduc and Radiological Dev

23

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Company of the control and consisted to the control and the controlled in the control of

C7-4 convex 4/7MHz 40mm radius transducer
and and the program and the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the ma
Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation Evaluation (ODE)

(Division Sign-Of

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 042326

24

CC5-1 microconvex 1/5MHz 15mm radius transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal CephalicNNNNNNN (*1)N (*2)
Adult CephalicNNNNNNN (*1)N (*2)
CardiacNNNNNNN (*1)N (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • *1 B/M, B/PWD, B/C/ND, B/CFM/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (

ion (OBE)
David h. Segerson

(Division Sign-Off Division of Reproductive, Abdominal on Radiological Devices / nilhani

25

Prescription Use (Per 221 CFR 801.109)

T7-4 TEE phased array 4/7MHz transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
TransesophagealNNNNNNN (*1)N (*2)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Leparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • *1 B/M, B/PWD, B/C/FM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalua

vice Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
ind Radiological Devices
K042326

26

3DC5-1 motorized convex 1/5MHz 40mm radius transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

"1 BM, B/PWD, B/C/VD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Daniel A. Lyon

(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number

27

3DEC9-5 motorized microconvex 5/9MHz 10mm radius transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)
Intraoperative Neurological
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNNN (*1)N (*2)
TransvaginalNNNNNNN (*1)N (*2)
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • 1 BIM, BIPWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFMCWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE),

(Division Sign-Off

(Division Sign-Off) Division of Reproductive, and Radiological Devices

28

IOT7-4 convex 4/7MHz 40mm radius intraoperational transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)NNNNNNN (*1)N (*2)
Intraoperative NeurologicalNNNNNNN (*1)N (*2)
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNNN (*1)N (*2)
TransvaginalNNNNNNN (*1)N (*2)
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

1 BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Eval

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices. K04236
510(k) Number

29

10J7-4 linear 4/7MHz 38mm radius intraoperational transducer Diagnostic Ultrasound Indications for Use Form

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

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(specify)Other
(specify)
Ophthalmic
FetalNNNNNNN (*1)N (*2)
AbdominalNNNNNNN (*1)N (*2)
Intraoperative (specify)NNNNNNN (*1)N (*2)
Intraoperative NeurologicalNNNNNNN (*1)N (*2)
PediatricNNNNNNN (*1)N (*2)
Small Organ (specify)NNNNNNN (*1)N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalNNNNNNN (*1)N (*2)
TransvaginalNNNNNNN (*1)N (*2)
Transurethral
Intravascular
Peripheral VascularNNNNNNN (*1)N (*2)
Leparoscopic
MSK ConventionalNNNNNNN (*1)N (*2)
MSK SuperficialNNNNNNN (*1)N (*2)
Other (specify) (*3)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments:

  • *1 BM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
  • *2 Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ,

Concurrence of CDRH, Office of Device Evaluati

Evaluation (ODE):
David A. Legnon

(Division Sign-Off) Division of Reproductive, Abdominal and adjological Devices a 11 Sac Superbor