K160406 · FUJIFILM Sonosite, Inc. · IYN · Mar 16, 2016 · Radiology
Device Facts
Record ID
K160406
Device Name
FUJIFILM FC1 Ultrasound System
Applicant
FUJIFILM Sonosite, Inc.
Product Code
IYN · Radiology
Decision Date
Mar 16, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1550
Device Class
Class 2
Attributes
Pediatric, 3rd-Party Reviewed
Indications for 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: 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
Device Story
The FUJIFILM FC1 is a software-controlled, general-purpose diagnostic ultrasound system. It acquires and displays high-resolution, real-time ultrasound data using various imaging modes (B-mode, M-mode, Doppler). The system is operated by physicians and healthcare professionals in clinical settings. It processes inputs from compatible transducers to produce visual images and fluid flow analysis, aiding in clinical evaluation and decision-making. The device supports measurements and calculations for obstetrical, cardiac, and volume assessments, and includes ECG acquisition (non-diagnostic). It features wireless image transfer and storage on removable media. The system benefits patients by providing non-invasive diagnostic imaging and guidance for procedures like peripheral nerve blocks.
Clinical Evidence
No clinical studies were required to support the determination of substantial equivalence. Evidence is based on bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility (ISO 10993), and acoustic output characterization (IEC 62359, NEMA UD 2).
Technological Characteristics
The system is a software-controlled diagnostic ultrasound device. It supports linear, curved linear, and phased array transducers (1.0-15.0 MHz). Imaging modes include B-mode, M-mode, Tissue Harmonic Imaging, Pulse Inversion Harmonic Imaging, Compound Harmonic Imaging, Spatial Compound Imaging, Color Doppler (Velocity/Power/Directional), and Pulsed/Continuous Wave Doppler. It features a 12.1" LCD, battery/AC power, and 802.11 wireless support. Patient-contact materials comply with ISO 10993. Software follows IEC 62304 life cycle processes.
Indications for Use
Indicated for qualified physicians and healthcare professionals for ultrasound imaging or fluid flow analysis of the human body, including fetal/OB-GYN, abdominal, intra-operative (abdominal/vascular), pediatric, small organ (breast, thyroid, testicles, prostate), neonatal cephalic, trans-vaginal, musculoskeletal (conventional/superficial), adult/pediatric cardiac, and peripheral vessel applications.
Regulatory Classification
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.
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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.
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | |
| 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="text-align: left;"><span style="text-align: left;"></span><label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label></div> | <div style="text-align: left;"><span style="text-align: left;"></span><label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label></div> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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| Ultrasound System | I<br>db<br>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<br>unon<br>T<br>I<br>- |
| | 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<br>Doppler | Combined<br>(Spec.) | Other<br>(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<br>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,<br>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
2. Tissue Harmonic Imaging (THI)
3. Issue Doppler Imaging (IDI)
common problem 4: "Steep Needle Rolling"
5. 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.
2. Tissue Harmonic Imaging (THI)
3. Tissue Doppler Imaging (TDI)
4. 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<br>(Spec.) |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(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<br>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,<br>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:<br>Transducer:<br>Intended Use: FUJIFILM FCT Ultrasound System<br>C60xf/5-2 MHz Transducer<br>Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(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<br>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,<br>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
1. Tissue Harmonic Imaging (THI)
2. ?
3. Tissue Doppler Imaging (TDI)
5. Deep Neural Command
Special Cell Commanding
5. 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
2. Tissue Harmonic Imaging (THI)
3. Tissue Doppler Imaging (D)
4. Color M-mode Doppler (D)
5. Sealed Needle Forming Compound:
5.
Spatial Compounding
017.108 ЯНЭ IS 1999) ອະປ noitqirose19
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| | 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<br>ﺪ |
| rəsində məskun və qalınmışdır. Bu mənist | -0" ।<br>ડુ-દ: |
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| | 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<br>C |
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| | əsində kənd. Bu mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist və bir mənist |
| | T<br>I<br>سال الا المحافظ من المحافظ من المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحافظ المحمول |
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| mately<br>sinə aid bitki növü. İstinadlar Respublikası Suranın Suranın Suranın Suranın Suranın Suranın Suranın Suran Filmin Suran Filmin Suranın Suran Suran Suran S<br>resubsuri<br>ənimobda) əvvəl əsasən bir sənələrin əsasən ərazi varilər. (Tornəli) əvirlərəq qalının qalının qalının mənasının mən<br>ാവുന്നും പ്രാമാന് പ്രാഥവില (കുട്ടിട്ടാറും,മാന്യൻ പ്രാഥവുമായിരുന്നു. അവലംബം<br>ə (səbərliqosedir.<br>ാപ്രശസ്ത) വല്യത്തി വല്യത്തിനും പ്രവാഹന്യത്തിനു വലുംബതാവും പുറത്തേക്കും പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവാഹം പ്രവ<br>itsoildqA ไธวเนเ<br>ərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsin<br><br>ാ<br>əsinə aid bitki növü. İstinadlar Şahil Mənistan Şəhrin fəsiləsinə filmlərin fəsiləsinə filmlərin fəsiləsinə cinsinə aid bitki növü. İstinadlar Qaranın Qaran məna<br>ətindən (səsinə aid<br>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<br>ച്ച് അമ്പന്മവുമാ<br>ട്ടവുമുള്ള പ്രശ്ച<br>suimobdA<br>ലവന്നും പുറ<br>ടുടെ പ്രേല<br>വലാ<br>N<br>ZZ<br>ZZ<br>ZZ<br>B<br>מיני מועד באורך בחוק במקום במקום במקום ב<br>N<br>M<br>ZZZ<br>ZZ<br>ZZ<br>0Ma<br>N<br>N<br>ZZ<br>ZZ<br>N<br>മനാ<br>əpoli<br>noitsteqq fo<br>വറിയായ<br>N<br>N<br>ZZ<br>N<br>N<br>N<br>0+8 :000+8 :000+8 :00+<br>0+8;0W9+8;M+<br>0+8 ; W9+8 ;M+<br>0+8 : Wa+8 : Watter : +<br>:0+8;0Ma+8 :M<br>("Əədqəl" ("Əəqqiddən "Qarşıqlı" ("Əsasən" ("Qaraqlarının "Qaranın qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarının qalınmışdır. "Qaraqlarını<br>്ച് പ്രാപ്പ് പ്രാപ്പ് പുറത്തിന്റെ പ്രത്യേക്കും പ്രവ്യത്തിന്റെ പ്രത്യേക്കും പ്രവർത്തിച്ചു. പിട്ടുണ്ടു. പ്രത്യേക്കും പ്രവർത്ത<br>Othe<br>ുന്നു. പിട്ടുണ്ട്. വിശ<br>1,255 1,255<br>รี । | | | | | |
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.