Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose ultrasound system and does not mention AI, ML, or related terms in the device description, intended use, or performance studies summary.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" intended for "evaluation by ultrasound imaging or fluid flow analysis," which indicates its use in diagnosis rather than therapy.

Diagnostic

Yes
The 'Device Description' specifically states: "The FC1 Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system..."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes." This implies the presence of hardware components (transducers, display, etc.) necessary for acquiring and displaying ultrasound data, even though it is "software controlled." The performance studies also mention evaluation of electrical, thermal, mechanical, and acoustic output, which are characteristics of hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the FUJIFILM FC1 Ultrasound System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This is a diagnostic imaging system that works in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
Device Description: It describes a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data." This aligns with an imaging device, not a device that analyzes samples.
Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.

Therefore, the FUJIFILM FC1 Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FUJIFILM FC1Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Neonatal Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel

The FC1 Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

Fetal OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral Vessel

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX
90-IYN, 90-IYO, 90-ITX

Device Description

The FC1 Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body including: Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal organs and vascular, Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-cardiac and cardiac), Musculo-skeletal (Conventional and Superficial), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physicians and healthcare professionals

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)

Summary of Non-Clinical Tests:
The FUJIFILM FC1 Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.

Summary of Clinical Tests:
The FC1 Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133454, K152209

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.

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

March 16, 2016

FUJIFILM Sonosite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K160406

Trade/Device Name: FUJIFILM FC1 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 12, 2016 Received: February 16, 2016

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

1

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

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

510(k) Number (if known)	TBD
Device Name	FUJIFILM FC1 Ultrasound System
K160406
Indications for Use (Describe)	The FUJIFILM FC1Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
	Fetal - OB/GYN
	Abdominal
	Intra-operative (Abdominal organs and vascular)
	Pediatric
	Small Organ (breast, thyroid, testicles, prostate)
	Neonatal Cephalic
	Trans-vaginal
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Cardiac Adult
	Cardiac Pediatric
	Peripheral Vessel

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
----------------------	-------------	-------------------------------------------

3

| Ultrasound System | I
db
əld |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| S | t ຂຸບ ດາ ລະ ວ່າ ນາ ໄປ ນ ນາ ລະ ຣາ ໄປ ວ |
| | |
| | of the program of the program and the provinsity of the finish of the finish of the finish of the finish of the finish of the finish of the finish of the finish the finish of |
| | əsindən cinsinə aid bitki növü. İstinadlar Qaraqları Qaraqları Qaraqları Qaraqları Qaraqları Qaraqları Qaraqları Qaraqları Qaraqları Qaraqların Qaraqla
unon
T
I

|
| | ה שהונות ה |
| | only of the program and |

System:	FUJIFILM FC1 Ultrasound System
Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation					Combined (Spec.)	Other (Spec.)
	B	M	PWD	CWD	Color Doppler
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1-3,5
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Small Organ (breast, thyroid, testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Adult Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-rectal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-vaginal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-urethral	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Intra-luminal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Cardiac Adult	N	N	N	N	N	B+M; B+PWD; B+CWD; B+CD	1-3,5
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Peripheral vessel	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
System:	FUJIFILM FC1 Ultrasound System
Transducer:	C11xp/8-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	N	N	N	N	N	N
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal
organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Small Organ (breast, thyroid,
testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Adult Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-rectal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-vaginal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-urethral	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-luminal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Adult	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Peripheral vessel	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5

xibuəddə sidir təbun bəbbə =ヨ :AQ-1 vd bərbələ və şuqilsəibni wən =N

് ക്ലബ്ബം സ്വീകരക്കുന്നത്. അവലംബം പ്രസ്സിന്റെ സമ്പന്ത്രി സമ്പന്ത്രി സ്ഥിതിച്ചിട്ടുണ്ട്.
പ്രവേഷം ക്ലാപ്പിക്കുന്നത്. അവലംബം പ്രസ്സിന്റെ സമ്പന്ത്രി സ്ഥിതിച്ചിട്ടുണ്ട്. പ്രവേശത്

Tissue Harmonic Imaging (THI)
Issue Doppler Imaging (IDI)

common problem 4: "Steep Needle Rolling"

Spatial Compounding

001.108 ЯНЭ IS 109 (2 109) өгப полтаргаач

4

างอนุธยาราธา 7-8/qx ۲ ( ) — ตาง ค อรป าง) รถบที่ระบุทคโท อย่างอิง : 2-8. ↑ ค่าเร

xibuəddə siyi 1əbun pəbbə =ヨ 'AQ¬ Aq pərcələ vəzirəsi və itanın mən =N

:stuəmmo 0 lauoitibb A

് കാലിക്കുന്നത് ക്രിസ്ത്രിക്കുന്നത്. അവലംബം പുറത്തേ പ്രവേശങ്ങളും പ്രവിച്ചിത്രവും വിവ്യത്യ വിവ്യക്ഷിക്കുന്നത്.
അവലംബം പല്ലോസ് ക്രിമ്പ് കേരള സ്വാസത്തിന്റെ വിവ്യത്യ വിവ്യവ വിവ

imaging guidance for peripheral nerve block procedures. Color Doppler includes Power/Velocity/Variance.

Tissue Harmonic Imaging (THI)
Tissue Doppler Imaging (TDI)
Strain Rate Imaging

5.: Spatial compounding

2017.108 Яヨコ 12 1999) ອຂU noilqirose19

5

System:	FUJIFILM FCT Ultrasound System
Transducer:	C35xp/8-3 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation						Other
(Spec.)
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal
organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Small Organ (breast, thyroid,
testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Adult Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-rectal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-vaginal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-urethral	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-luminal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Adult	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Peripheral vessel	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
System:
Transducer:
Intended Use: FUJIFILM FCT Ultrasound System
C60xf/5-2 MHz Transducer
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal
organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Pediatric
Small Organ (breast, thyroid,
testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

าควบเรทธานี

xibuəddə siyi 1əbun pəbbe =ヨ :AQ¬ vq pərcələ (Isnoivəsd =Ə :uoi)rəsibui wəu =N

sinə mənin əsasən ən ən ən ən ən ən ən ən ən qalındığı və qalınmışdır. Bu mənist

് കാലിക്കുന്നു. കുറുകയുടെ വിക്കുന്നത്. അവലംബം പ്രവിശ്വീ മത്സ് വിവർശന ക്ഷേത്രം പ്രവിച്ച ക്ലാപ്പോൾ പ്രവേശം കാലാവും പ്രവ
കാലക്കുന്നു. സ്വീമത്തിനും ശ്രമായ പ്രവേശക്ഷേത്രം പ്രവേശക

Tissue Harmonic Imaging (THI)
?
Tissue Doppler Imaging (TDI)
Deep Neural Command
Special Cell Commanding
Spatial Compounding

017.108 ЯНЭ IS 1999) ອະປ noitqirose19

6

าความรายา โ ร-ราชวัง ออน 107 ออน 107 รางบุคคลที่ไป อย่างอิง (1) อุประเทศที่เป็น – ค-ร. ) อุปรโ

xibuəddə siyi 1əbun pəbbe =ヨ :AQ¬ vq pərcələ (Isnoivəsd =Ə :uoi)rəsibui wəu =N

sinə mənin əsasən ən ən ən ən ən ən ən ən ən qalındığı və qalınmışdır. Bu mənist

് കാലിക്കുന്നത് സമ്മാനം കുറുക്കുന്നത്. അവലംബം പ്രവീശയിക്കുന്നു. പ്രവേശങ്ങളും പ്രവീകരിച്ചു. പ്രവ
കാലക പ്രവേശ ശ്രമായ ശ്രമായ കുറ്റാവും കാലിക്കുന്നു. പ്രവേശക്ഷേത്രം പ്രവേശക്ഷേത്

Tissue Harmonic Imaging (THI)
Tissue Doppler Imaging (D)
Color M-mode Doppler (D)
Sealed Needle Forming Compound:

Spatial Compounding

017.108 ЯНЭ IS 1999) ອະປ noitqirose19

7

| I | י מנוי
I
) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | əldə bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində qalınmışdır. B
ﺪ |
| rəsində məskun və qalınmışdır. Bu mənist | -0" ।
ડુ-દ: |
| | - |
| | t
l |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | r |
| | suonesibul punoseund ວາງຣຸດບຸຣິຍາ |
| | ﺃﺷﺨﺎﺹ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
C |
| | |
| | əsində kənd. Bu mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist |
| | T
I
سال الا المحافظ من المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحمول |
| | - |



C

| mately
sinə aid bitki növü. İstinadlar Respublikası Suranın Suranın Suranın Suranın Suranın Suranın Suranın Suran Filmin Suran Filmin Suranın Suran Suran Suran S
resubsuri
ənimobda) əvvəl əsasən bir sənələrin əsasən ərazi varilər. (Tornəli) əvirlərəq qalının qalının qalının mənasının mən
ാവുന്നും പ്രാമാന്‍ പ്രാഥവില (കുട്ടിട്ടാറും,മാന്യൻ പ്രാഥവുമായിരുന്നു. അവലംബം
ə (səbərliqosedir.
ാപ്രശസ്ത) വല്യത്തി വല്യത്തിനും പ്രവാഹന്യത്തിനു വലുംബതാവും പുറത്തേക്കും പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവ
itsoildqA ไธวเนเ
ərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsin

ാ
əsinə aid bitki növü. İstinadlar Şahil Mənistan Şəhrin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Qaranın Qaran məna
ətindən (səsinə aid
rın suranın suran və mərkəzi və bir və mərkəzi və bir və mərkəzi və bir və mərkəzi və bir və mərkəzi və bir və mərkəzi və bir və mərkəzi və mərkəzi və mərkəzi və qarın qalın
ച്ച് അമ്പന്മവുമാ
ട്ടവുമുള്ള പ്രശ്ച
suimobdA
ലവന്നും പുറ
ടുടെ പ്രേല
വലാ
N
ZZ
ZZ
ZZ
B
מיני מועד באורך בחוק במקום במקום במקום ב
N
M
ZZZ
ZZ
ZZ
0Ma
N
N
ZZ
ZZ
N
മനാ
əpoli
noitsteqq fo
വറിയായ
N
N
ZZ
N
N
N
0+8 :000+8 :000+8 :00+
0+8;0W9+8;M+
0+8 ; W9+8 ;M+
0+8 : Wa+8 : Watter : +
:0+8;0Ma+8 :M
("Əədqəl" ("Əəqqiddən "Qarşıqlı" ("Əsasən" ("Qaraqlarının "Qaranın qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarını
്ച് പ്രാപ്പ് പ്രാപ്പ് പുറത്തിന്റെ പ്രത്യേക്കും പ്രവ്യത്തിന്റെ പ്രത്യേക്കും പ്രവർത്തിച്ചു. പിട്ടുണ്ടു. പ്രത്യേക്കും പ്രവർത്ത
Othe
ുന്നു. പിട്ടുണ്ട്. വിശ
1,255 1,255

รี ।































	oəds) jəqic

xibuəddə siyi təbun bəbbə =ヨ :AQ¬ vq pərsələ visnoivərd =¶ :uoitisəibui wən =N

:stuəmmo 0 lauoitibbA

Imaging changes to peripheral nerve roots
associated with inflammatory demyelinating
polyradiculoneuropathy (IDP)

Tissue Harmonic Imaging
Tissue Imaging
Tissue Doppler Imaging (TDI)
Steep Noodle Broth in
Spatial Compoundin

(୧୦୮.୮08 ମସିହାର ମଧ୍ୟ ୮୬ ଅଟେ । ଏହା ପ୍ରତିଶତ ପ୍ରତିଶତ ପ୍ର

8

| I
גם | I
əldə qalınmışdır. Bu mənist və qalınmışdır. Bu mənist və bir mənist və qalınmışdır. Bu mənist və qalınmışdır. Bu mənist və bir mənist və qalınmışdır. Bu və bir və qalınmışdı
)
د |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| əsindən filmləri fəsiləsinin cinsinə aid bitki növü. İstinadlar Respublikası Respublikası Respublikası Respublikası Respublikası Respublikası | 1.8-6 |
| | -
1
J |
| | ່າງ |
| | |
| | əsində kənd. Bu mənist və qalınmışdır. Bu mənist |
| | uno -
1

| | निनि
/dx0G7z |
| | 9-GI/ |

maters			unisit uneseaply 13 Ultrassun
ransdicer			��
əsində məşğul və bir mənist						smud ədi to sisylens wolf birin 10 prinsession in bunun sonra isə vəzi

oitsoilqqA lвзіліІЗ					oits19q0 to ebol
	B	M	ama	മനാ	വഠിവാ	(rəsdə)	əsindən cinsinə aid bitki növü. İstinadlar Rəsmin Cəsinə Qaran mənist

ാണ്യമന്ത്രിന്റ
late न
suimobdA	N	N	N		N	0+8 :000+8 :M+
əsinə aid bitki növü. İstinadlar Qırmızı	N	N	N		N	#8 :00#a+8 :M+	1,25


oidossonsda
ərin siyasət və qalınmışdır. Bu mərkəzi və bir mənist	N	N	N		N
ionin (sisteminə (sələbə) —	N	N	N		7	2+8 : Wa+8 : Wa+8 :M+	1,25 1,24,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74,74
		N
	N		N		N	0+8 ; W9+8 ;M+	ەﺗﻞەﺭ ﺗﺎﺭﯨﺦ ﺋﺎﺗﺘﯩﻠﯩﺮ ﻗﺎﺯﺍﺭ ﺋﺎﺗﯩﻠﯩﺪﯨﻐﺎﻥ ﻗﺎﺯﺍﺭ ﺋﺎﺗﯩﻠﯩﺪﯨﻐﺎﻥ ﻗﺎﺯﺍﺭ ﺋﺎﺗﯩﻠﯩﺪﯨﻐﺎﻥ ﻗﺎﺯﺍﺭ ﺋﺎﺗﺘﯩﻠﯩﺮ ﻗﺎﺯﺍﺭ ﺋﺎﺗﺘﯩﻠﯩﺮ ﻗﺎﺯﺍﺭ ﺋﻮﺗﺘﯘﺭﯨﺴﻰ ﺋﺎﺗﺘﯩﻠﯩﺮ ﻗﺎﺯﺍﺭ ﺋﻮﺗﺘﯘﺭﯨﺴﻰ ﺋﻮﺗﺘﯘﺭﯨﺴﻰ ﺋﻮﺗﺘﯘﺭﯨﺴﻰ ﺋﻮﺗﺘﯘﺭﯨ

ടുാലു-ഭവങ്
suipev-suer
rın suranın suran mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənasının mənas

ുക്കുവോ) .പിട്ടു-വന്നു എന്നാവ	N	N	N		N	#8 ; W9+8 ;M
ວານອຸດນຣ) .ໄອ ສຣ-ວາມ ວຣນ	N	N	N		7	0+8 :0Md+8 :M+	1,24,4 1,254,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,7
5
ല്പന്നും പ്രാ
əsindən fəsiləsinin cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmləri fəsiləsinin cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləs
ാന്ന് വാക്കാലിന്റെ വിശ്വാസ്ത്രിക്കുന്നതാക്കുന്നതാക്കുന്നു. അവലംബം

വലാ
əsindən cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmləri fəsiləsinin fəsiləsinin cinsinə aid bitki növü. İstinadlar Azərbaycan Filmin fəsi
əsindən cinsinə aid bitki növü. İstinadlar Respublikasının Filmin Filmin Filmin Film Say	N	N	N		N	0+8;0W9+8;M+	G'Z'V
n sinfinin cinsinə aid bitki növü. İstinadlar Respublikası Şamil Say Say
mətəyə				וחדש בורג בורד בריטונוסטטענטער בריטנו
Transboccocer			າ ອວ ມ
əsi tərəfindən cinsinə aid bitki növü. İstinadlar Respublikasının filmləri fəsiləsinin filmlərin filmləri filmləri filmləri filmləri filmləri filmləri						ร โงงงา แยนทุน อป to sisvlede wolf binh 10 ถูกเขียนที่ bunosently ว่ารอนทอย
	:swollo
oillesilddA lesinilə					responsible of the september of the series of the series of the series of the series of the series of the series of the series of the series of the series of the series of th
	B	M	ama	amo	əlddən
വിവാ	(rəsmidmət (film, 1994) Azərbaycan Respublikasının mərkəzi və bir mənist	i əhli olan sənət qalında çəkili və qalında çəkili və qalında çəkilir. Bu qalında çəkili qalında çəkili qalında çəkili qalındır. Bu qalında çəkili qarşıqların qalında çəkili
ാന്ധിട്ടുന്നത്. അവലംബം കേരള സ്ഥാനം സ്വീതന്ത്രിക്കുന്നു.
lətə qalan məlumatı və qalınmışdır. Bu mənist və bir mənist və bir mənist mənist mənist mənist mənist mənasını qalınmışdır. Bu mənist	N	N			N	10+8 :00#48 :M+	G'Z'I
lenimobdA

รินทางไปส์
onnell) eviteredo-sui
oidossounds
əsinə aid bitki növü. İstinadlar Şəhər Şəhrin fəsiləsinə filmləri fəsiləsinə filmləri fəsiləsinin cinsinə aid bitki növü. İstinadlar Azərbaycan Filmin fəsilə
ər (ətələrin əsasənd) məğrul (əsrin əsasən (əsrin əsasən (əsrin əsasən (əsrin əsasən) və qalınmışdır. (əsr və qalınmışdır. 1

ərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Qaranl
əsinə aid bitki növü. İstinadlar Şəhər Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin Şəhrin
ിലോക്ക-ടവല
suipsv-suer	N	N				0+8 :0W9+8 :M+	ק'Σ, Γ
lərin mənasının sənət qalınması və qalınması və qalınması və qalınması və qalınması və qalınması və qalınması və qalınması və qalınması və qalınması və qalınmışdır. Bu və qa
വിലാ-സമ്പ. (വാലം-ഭവല
rusculoskel. (Convent.
ərin qurğuların sahəsində məsul
ntra-luminal-luminal
(cəsinin cinsinə aid bitki növü. İstinadlar Qaranın Qaran mənasının fəsiləsinə filmləri fəsiləsinin cinsinə aid bitki növü. İstinadlar Qaranın Qaran mənasının f
ป็นปรัส วิธีเป็นตัว
ointsibe9 วิธีเขาย3
.buss) lespendoss-suer
tərək (specifi
əsindən cinsinə aid bitki növü. İstinadlar Respublikasının filmləri Filmin Film Film Film Film Film Film Film Film Film Film Film Film Film Film Film F
in fəsiləsinin cinsinə aid bitki növü. İstinadlar Cinsino Cənubi Cəsinə Qaran fəsiləsinin cinsinə aid bitki növü. İstinadlar Cinsinə aid bitki növü. İstinadlar

indən siya əsasən bərbə səs və qalında və isə çəkilməsi və inqilisəsibəsi və q

്കുന്നു.

അവലംബം pur

Spatial Compounding

2017.08 Яヨコ 12 1999) ອະປ noitqiroser

9

ലാവുടന്നു ഔഷധവേ ( 1 – നാറ് ലോഗ്ഗം) 1 ( 2 ലേഗ്ഗങ്ങളും) ( 2 ) 2 ) 1 - ) - )

xibuəddə siyi 1əpun bəbbə =ヨ :AQ¬ vq bərcələ (Isnoivərd =님 ;uqitesibu! wən =M

:stuəmmon Comments

് കാലിക്കുന്നു.
അവലംബം സ്വാത്തര ശ്രമന്ത്രം വിശ്വാസവും വേണ്യ വിവിശ്വീ വിവ്യക്ഷിക്കുന്നു. പ്രവേഹം വിക്ഷേ പ്രവേഹം വിക്ഷേ പ്രവേഹം വിക്ഷേ പ്രവേഹം വിക്ഷേത്രം വിവ്യത്യ വിവ്യക്ഷിക്

Imaging guidance for peripheral nerve block procedures. Color Doppler Includes F
2. Tissue Harmonic Ima0

Tissue Doppler Imaging (TDI)
Steep Needle Rolling
Spatial Compounding

(୧୦୮.୮08 ମସିହାର ମଧ୍ୟ ୮୬ (୧୯୮୮) ଚଟ୍ରିୟ ପ୍ରତିମା

10

System:	FUJIFILM FC1 Ultrasound System
Transducer:	L25xp/13-6 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Small Organ (breast, thyroid, testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Adult Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-rectal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-vaginal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-urethral	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Intra-luminal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Cardiac Adult	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Peripheral vessel	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5

างอิงเทรา อ-ε ΓγαχεΣ | – ตางวิ อรป างข้ รถบท้ายว่าความการ ที่ไป ว่ารอนุทธิร์ – 8-6. ที่ 9 | ประ

xibuəddə siyi 1əbun pəbbe =ヨ :AQ¬ vq pərcələ (Isnoivəsd =Ə :uoi)rəsibui wəu =N

sinə mənin əsasən ən ən ən ən ən ən ən ən ən qalındığı və qalınmışdır. Bu mənist

് ക്ലാസ് സ്റ്റാമ്യൂക്കുവികൾ വരെ പ്രവർത്തിച്ചിരിക്കുന്നു. പ്രവേശങ്ങളും പ്രവിച്ചിത്രവും വിട്ടു.
പ്രവേഹമേണ്ട് (പ്രാമരുവരുന്നും വേട്ടി വേളി വേണ്ട് വലിക്കുന്നത് വിവ്യത്യേക്കുന്ന

Tissue Harmonic Imaging (THI)?
Tissue Doppler Imaging (TDI)?

Tissue Doppler Imaging (TDI)
Strain Rate Imaging
Speckle Tracking
Ionic and Polar Covalent Compounds are often hydrated.

Spatial Compounding

017.108 ЯНЭ IS 199) ອະປ noitqirose19

11

System:	FUJIFILM FC1 Ultrasound System
Transducer:	L38xp/10-5 MHz Transducer
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Fetal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Abdominal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Abdominal organs and vascular)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-operative (Neuro.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,4,5
Laparoscopic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Small Organ (breast, thyroid, testicles, prostate)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Neonatal Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Adult Cephalic	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-rectal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-vaginal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-urethral	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esoph. (non-Card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Convent.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Musculo-skel. (Superfic.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Intra-luminal	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Adult	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Cardiac Pediatric	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Trans-esophageal (card.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Peripheral vessel	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5
Other (spec.)	N	N	N	N	N	B+M; B+PWD; B+CD	1,2,5

างอิงเทรา 7-01 | 4x8 ปี – ตาง ๆ อรป างา รถบท้ายว่า พ.ศ. 2017 อัลบั้ม – 8-6. ที่ 11 ประ

kibirəddə sini, 1994-cü ildə və baxın və bəxsələ visnoivəsq = 1 :noilsəlibrii wən =11

:stuəmmon Comments:

് കാലിക്കുന്നത് ക്ലാസ്സ് ക്രിമ്പ് ശേരി പ്രവർത്തനം പ്രവർത്തന കാലിക്കുന്നു. പ്രവിച്ച കാലിക്കുന്നു.
അവലംബം പ്രവേശ ക്ഷേത്രം പ്രവേശവാസ്ത്രവും വലിപ്പി മന്ത്രിയ വിവ്യക്ഷിക്കുന്നു.

Tissue Harmonic Imaging (THI)
Tissue Doppler Imaging (TDI)
Steep Needle Profiling
Spatial Compounding

(୧୦୮.୮08 ମସିହାର ଅଧିକ ଅଟନ୍ତି । ୧୯୮୮ ମସିହାର ଅଧିକ ସାହା ପ୍ରାୟ ସହ ପ୍ରତି

12

າອວບຸຮາເສາ I - ວິໄຊx LSA – ຕາດຈີ ອຂປ າດໄຂເວທີການປະຣານໄປ ວ່າຂອງນາໄປ ວ່າຂອງແຍກ

xibuədqə siyi 1əbun bəbbə =ヨ :AQ¬ vq bərbələ vəzifəsi və çəkiləri vən =V1

ະຣານອຸພາບວົງ ໂຣແດງເຖິງນັກສ

Tissue Harmonic Imaging (THI)
Tissue Doppler Imaging (TDI)

4: Steep Needle Profiling

Spatial Compounding

001.108 ЯНЭ IS 199 (2 199) өгப полтайтогөтЧ

13

510(K) Summary

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1) Submitter's name, address, telephone number, contact person:

FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904

| Corresponding Official: | Scott Paulson
Director, Regulatory Affairs and Quality Systems |
|-------------------------|-------------------------------------------------------------------|
| E-mail: | Scott.Paulson@sonosite.com |
| Telephone: | (425) 951-6926 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | November 22, 2015 |

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

FUJIFILM FC1 Ultrasound System (subject to change)

Classification Names

Name	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Identification of the predicate or legally marketed device:

SonoSite Edge Ultrasound System K133454 (primary predicate device) SonoSite X-Porte Ultrasound System K152209

4) Device Description:

The FC1 Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes.

5) Intended Use:

The FC1 Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

14

Fetal OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral Vessel

6) Technological Characteristics:

FC1, Edge and X-Porte Ultrasound Systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

| Feature | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | FC1 Ultrasound System
(this submission) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body |
| Indications for
Use | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs
and vascular)
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Needle guidance | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs
and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Needle guidance | Fetal - OB/GYN
Abdominal
Intraoperative (Abdominal organs
and vascular)
Pediatric
Small Organ (breast, thyroid,
testicles, prostate)
Neonatal Cephalic
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
Needle guidance |
| Transducer
Types | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal | Linear Array
Curved Linear Array
Intracavitary
Phased Array |
| Transducer
Frequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Modes of
Operation | B-Mode
Tissue Harmonic Imaging | B-Mode
Tissue Harmonic Imaging | B-Mode
Tissue Harmonic Imaging |
| Feature | SonoSite X-Porte
Ultrasound System
(K152209) | SonoSite Edge
Ultrasound System
(K133454) | FC1 Ultrasound System
(this submission) |
| | Pulse Inversion Harmonic Imaging
M-mode
Velocity Color Doppler
Color Power Doppler
Pulsed Wave Doppler
Pulsed Wave Tissue Doppler
Continuous Wave Doppler, ECG | Pulse Inversion Harmonic Imaging
M-mode
Velocity Color Doppler
Color Power Doppler
Pulsed Wave Doppler
Pulsed Wave Tissue Doppler
Continuous Wave Doppler, ECG | Pulse Inversion Harmonic Imaging
Compound Harmonic Imaging
Spatial Compound Imaging
M-mode
Velocity Color Doppler
Color Power Doppler
Directional Color Power Doppler
Pulsed Wave Doppler
Pulsed Wave Tissue Doppler
Continuous Wave Doppler, ECG |
| PW Doppler | Available | Available | Available |
| CW Doppler | Available | Available | Available |
| Patient
Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Complies with ISO 10993 |
| System
Characteristics | 12.1" Capacitive touch screen
interface
19" LED LCD HD monitor
256 gray shades on LED LCD
System operates via battery or AC
power
Input: 100 - 240 VAC, 50/60 Hz
Output 1: 24VDC output, 275 W
max
Output 2: 100-240VAC, 50-60 Hz
(AC Printer) | Hand carried display and controls
Single 12.1" Liquid Crystal Display
(LCD)
256 gray shades on LCD
System operates via battery or AC
power
100 - 240V options, 50/60 Hz,
15VDC output | Hand carried display and controls
Single 12.1" Liquid Crystal Display
(LCD)
256 gray shades on LCD
System operates via battery or AC
power
100 - 240V options, 50/60 Hz,
15VDC output |
| | Ability to perform measurements
and calculations in the following:
obstetrical, cardiac, volume, M-
mode, PW and CW Doppler
ECG acquisition and display
capabilities (non-diagnostic)
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media
Measurement on Recalled
Images.
Wireless 802.11 (a/b/g/n) support
for image transfer | Ability to perform measurements
and calculations in the following:
obstetrical, cardiac, volume, M-
mode, PW and CW Doppler
ECG acquisition and display
capabilities (non-diagnostic)
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media
Wireless 802.11 (a/b/g) support for
image transfer | Ability to perform measurements
and calculations in the following:
obstetrical, cardiac, volume, M-
mode, PW and CW Doppler
ECG acquisition and display
capabilities (non-diagnostic)
CW/PW Doppler Audio
Spectral Doppler Audio and image
storage on removable media
Wireless 802.11 (a/b/g) support for
image transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 |

15

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The FUJIFILM FC1 Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.

16

The FUJIFILM FC1 Ultrasound System is designed to comply with the following FDA recognized standards.

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk management process
IEC 60601-1	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard:
Usability
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle
processes
IEC 62359	IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Test
methods for the determination of thermal and mechanical indices related to medical
diagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medical
devices
NEMA UD 2-2004	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Summary of Clinical Tests:

The FC1 Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

8) Conclusion:

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The FC1 system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electro-medical device safety standards. FUJIFILM SonoSite, Inc. believes that the FC1 Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.