(29 days)
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 highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes.
The provided text is a 510(k) Summary for the FUJIFILM FC1 Ultrasound System. It details the device's characteristics and its equivalence to legally marketed predicate devices, but it does not contain information about specific acceptance criteria, a study proving performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies. The document states that clinical studies were not required.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria or report specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety standards compliance, and intended use.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document states:
"The FC1 Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical studies requiring ground truth establishment were conducted.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies requiring adjudication were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The document describes an ultrasound system, not an AI or CAD system designed to assist human readers. Moreover, no clinical studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance. No clinical studies were performed.
7. The Type of Ground Truth Used
Not applicable, as no clinical studies requiring ground truth were conducted.
8. The Sample Size for the Training Set
Not applicable, as the device is not an AI/ML algorithm that requires a training set in the conventional sense. The "study" mentioned in the request refers to the overall evaluation for 510(k) clearance, which did not involve clinical performance data or training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as the device is not an AI/ML algorithm, and no training set with established ground truth was used.
Summary of what the document does provide regarding "studies" and performance:
The document primarily details the non-clinical tests conducted to ensure safety and effectiveness and establish substantial equivalence to predicate devices. These include:
- Electrical, thermal, mechanical, and EMC safety evaluations: The device was found to conform to applicable mandatory medical device safety standards.
- Cleaning/disinfection evaluation.
- Biocompatibility evaluation.
- Acoustic output evaluation.
- Quality assurance processes: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation were employed.
- Compliance with FDA recognized standards: A list of ISO and IEC standards is provided (e.g., ISO 10993-1, IEC 60601-1, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004).
The "study that proves the device meets the acceptance criteria" in this context is the collection of these non-clinical evaluations and the demonstration that the device's technological characteristics, intended use, and safety profiles are substantially equivalent to existing predicate devices (SonoSite Edge K133454 and SonoSite X-Porte K152209), which themselves have established safety and effectiveness.
The document concludes that "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." This is the primary "proof" for its acceptance.
{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 SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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.
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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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"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 |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
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| Ultrasound System | Idbəld |
|---|---|
| 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 QaraqlaunonTI- | |
| 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 | ColorDoppler | 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 (Abdominalorgans 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 | ColorDoppler | 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 (Abdominalorgans 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 SystemC60xf/5-2 MHz TransducerDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | 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 (Abdominalorgans 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 מנויI) |
|---|---|
| əldə bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində bir şəhərində qalınmışdır. Bﺪ | |
| rəsində məskun və qalınmışdır. Bu mənist | -0" ।ડુ-દ: |
| - | |
| tl | |
| 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 ﺍﻟﻤﺴﺘﻮﻯC | |
| əsində kənd. Bu mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist | |
| TIسال الا المحافظ من المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحمول | |
| - | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| IC | |
| ר38xp/ | |
| 9-81/ |
| matelysinə aid bitki növü. İstinadlar Respublikası Suranın Suranın Suranın Suranın Suranın Suranın Suranın Suran Filmin Suran Filmin Suranın Suran Suran Suran Sresubsuriənimobda) əvvəl əsasən bir sənələrin əsasən ərazi varilər. (Tornəli) əvirlərəq qalının qalının qalının mənasının mənാവുന്നും പ്രാമാന് പ്രാഥവില (കുട്ടിട്ടാറും,മാന്യൻ പ്രാഥവുമായിരുന്നു. അവലംബംə (səbərliqosedir.ാപ്രശസ്ത) വല്യത്തി വല്യത്തിനും പ്രവാഹന്യത്തിനു വലുംബതാവും പുറത്തേക്കും പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവitsoildqA ไธวเนเərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinാəsinə aid bitki növü. İstinadlar Şahil Mənistan Şəhrin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Qaranın Qaran mənaətindən (səsinə aidrın 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 qalınച്ച് അമ്പന്മവുമാട്ടവുമുള്ള പ്രശ്ചsuimobdAലവന്നും പുറടുടെ പ്രേലവലാNZZZZZZBמיני מועד באורך בחוק במקום במקום במקום בNMZZZZZZZ0MaNNZZZZNമനാəpolinoitsteqq foവറിയായNNZZNNN0+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. "Qaraqlarını്ച് പ്രാപ്പ് പ്രാപ്പ് പുറത്തിന്റെ പ്രത്യേക്കും പ്രവ്യത്തിന്റെ പ്രത്യേക്കും പ്രവർത്തിച്ചു. പിട്ടുണ്ടു. പ്രത്യേക്കും പ്രവർത്തOtheുന്നു. പിട്ടുണ്ട്. വിശ1,255 1,255รี । | |||||
|---|---|---|---|---|---|
| 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}------------------------------------------------
| Iגם | Iəldə 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 |
| -1J | |
| ່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 1,254,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,747,474,75 | |
| 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 | əlddənവിവാ | (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 PaulsonDirector, 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-PorteUltrasound System(K152209) | SonoSite EdgeUltrasound System(K133454) | FC1 Ultrasound System(this submission) |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody |
| Indications forUse | OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)PediatricSmall Organ (breast, thyroid,testicle, prostate)Trans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance | OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance | Fetal - OB/GYNAbdominalIntraoperative (Abdominal organsand vascular)PediatricSmall Organ (breast, thyroid,testicles, prostate)Neonatal CephalicTrans-vaginalMusculo-skel. (Convent.)Musculo-skel. (Superfic.)Cardiac AdultCardiac PediatricPeripheral VesselNeedle guidance |
| TransducerTypes | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal | Linear ArrayCurved Linear ArrayIntracavitaryPhased Array |
| TransducerFrequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Modes ofOperation | B-ModeTissue Harmonic Imaging | B-ModeTissue Harmonic Imaging | B-ModeTissue Harmonic Imaging |
| Feature | SonoSite X-PorteUltrasound System(K152209) | SonoSite EdgeUltrasound System(K133454) | FC1 Ultrasound System(this submission) |
| Pulse Inversion Harmonic ImagingM-modeVelocity Color DopplerColor Power DopplerPulsed Wave DopplerPulsed Wave Tissue DopplerContinuous Wave Doppler, ECG | Pulse Inversion Harmonic ImagingM-modeVelocity Color DopplerColor Power DopplerPulsed Wave DopplerPulsed Wave Tissue DopplerContinuous Wave Doppler, ECG | Pulse Inversion Harmonic ImagingCompound Harmonic ImagingSpatial Compound ImagingM-modeVelocity Color DopplerColor Power DopplerDirectional Color Power DopplerPulsed Wave DopplerPulsed Wave Tissue DopplerContinuous Wave Doppler, ECG | |
| PW Doppler | Available | Available | Available |
| CW Doppler | Available | Available | Available |
| PatientContactMaterials | Complies with ISO 10993 | Complies with ISO 10993 | Complies with ISO 10993 |
| SystemCharacteristics | 12.1" Capacitive touch screeninterface19" LED LCD HD monitor256 gray shades on LED LCDSystem operates via battery or ACpowerInput: 100 - 240 VAC, 50/60 HzOutput 1: 24VDC output, 275 WmaxOutput 2: 100-240VAC, 50-60 Hz(AC Printer) | Hand carried display and controlsSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCDSystem operates via battery or ACpower100 - 240V options, 50/60 Hz,15VDC output | Hand carried display and controlsSingle 12.1" Liquid Crystal Display(LCD)256 gray shades on LCDSystem operates via battery or ACpower100 - 240V options, 50/60 Hz,15VDC output |
| Ability to perform measurementsand calculations in the following:obstetrical, cardiac, volume, M-mode, PW and CW DopplerECG acquisition and displaycapabilities (non-diagnostic)CW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaMeasurement on RecalledImages.Wireless 802.11 (a/b/g/n) supportfor image transfer | Ability to perform measurementsand calculations in the following:obstetrical, cardiac, volume, M-mode, PW and CW DopplerECG acquisition and displaycapabilities (non-diagnostic)CW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaWireless 802.11 (a/b/g) support forimage transfer | Ability to perform measurementsand calculations in the following:obstetrical, cardiac, volume, M-mode, PW and CW DopplerECG acquisition and displaycapabilities (non-diagnostic)CW/PW Doppler AudioSpectral Doppler Audio and imagestorage on removable mediaWireless 802.11 (a/b/g) support forimage 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 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements 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 - Collateralstandard: 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: Generalrequirements 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 ultrasonicmedical diagnostic and monitoring equipment |
| IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycleprocesses |
| IEC 62359 | IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Testmethods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)] |
| ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medicaldevices |
| 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.
§ 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.