MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT

{0}------------------------------------------------ # 510(k) Summary # Fukuda Denshi Model FF Sonic UF-750XT Diagnostic Ultrasound System with option 3D imaging unit (UF-750XT-3DU) # Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92 The assigned 510(k) number is: KOB26 S6 - Fukuda Denshi USA, Inc. Submitter: 17725 NE 65th Street, Building C Redmond, WA 98052 TEL: 425-881-7737 FAX: 425-869-2018 - Contact Person: Loran Van Noy Senior Director Fukuda Denshi USA, Inc. 17725 NE 65th Street, Building C Redmond, WA 98052 TEL: 425-881-7737 FAX: 425-869-2018 Date Prepared: August 4, 2008 | Device Name | Model Number | |-----------------------------------------------------------------------|--------------| | Fukuda Denshi Model FF Sonic UF-750XT<br>Diagnostic Ultrasound System | UF-750XT | | 3D imaging Unit | UF-750XT-3DU | General Purpose Ultrasound Scanner with Doppler Common Name: Classification: Regulatory Class: II Review Category: Tier II | | CFR Number | Product Code | |---------------------------------------------|------------|--------------| | Ultrasonic Pulsed Doppler Imaging<br>System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | {1}------------------------------------------------ # Marketed Device: The subject device is substantially equivalent in its technologies and functionality to the original Fukuda Denshi Diagnostic Ultrasound System that is already cleared under premarket notification number K#033209, and another predicate device noted below: | Prodiogra<br>4.26, 11.12.<br>A | <br>Manutacturer<br>STATE A CAN CONSUL CONSULT CONSULTION CONSULTION CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION | vioue | FREE ARL LOLL COLLEGE OF CO<br>111 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | t<br>મ્પાડા<br>No. of Acres of Children Company of Children Company of Children Company of Children Come of Children Come of Children Come of Children Come of Children Come of Children Come | 10001<br>medica<br>Submit<br>10.000<br>ANNO ALL AND GALL LE | ALL AND ON RELIGION OF COLLECT | CHANNER AND E RELL E RELL I BERESS OF SECREED OF SECTION OF SERVE A<br>17 HAE 7 7 5 0<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Device Description: The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode). > The device consists of two parts: the scanner, and one of up to seven (7) different probes. In addition, the probe sclector unit provides two probes connection capability. The Fukuda Denshi Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, and musculoskeletal (general and superficial) exams. This subject modified Ultrasound System also provides 3D imaging (Guided free hand 3D and Free hand 3D) with an optional 3D imaging unit (UF-750XT-3DU). New measurement functions have been added by the option 3D imaging unit (UF-750XT-3DU). No new transducers are being added and are not the subject of this submission. # Intended Usc: The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes, etc.), cardiac (adult and pediatric), transvaginal, peripheral vessel, and musculo-skeletal (Conventional and Superficial). The device incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The device is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use. # Technological Characteristics: The FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) incorporates the same fundamental technologies as the predicate devices. The {2}------------------------------------------------ probes cleared with the predicate device (FF Sonic UF-750XT, K#033209) are used for the subject device. The device has been tested as Track 3 devices per the FDA guidance document "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers" issued in Scptember, 1997. The Acoustic Output is measured and calculated per NEMA UD 2 Acoustic Output Mcasurement Standard for Diagnostic Ultrasound Equipment: 2004. All transduccrs used with the FF Sonic UF-750XT are track 3 transducers and testing validated that no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0. All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device. The technology characteristics of the FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) do not affect the safety or efficacy of the device. Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or arc addressed in the system hazard analysis or in the system validation. #### Testing: Laboratory Testing: Laboratory testing was conducted to verify that the Fukuda Denshi FF Sonic Model UF-750XT with option 3D imaging unit (UI-750XT-3DU) met all design specification and was substantially equivalent to the current legally marketed predicate devices. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility and effectiveness of cleaning and disinfection. # Applicable Standards: The FF Sonic UF-750XT with option 3D imaging unit (UF-750XT-3DU) conforms to the following Standards: - · NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 - NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices: 2004 - IEC 60601-1 . - · IEC 60601-1-1 - · IEC 60601-1-2 - · IEC 60601-1-4 - · IEC 60601-2-37 # Clinical Test: No clinical testing was required Conclusion: The conclusion drawn from the testing of the Fukuda Denshi FF Sonic Model UF-750XT Diagnostic Ultrasound system with option 3D imaging unit (UF- {3}------------------------------------------------ 750XT-3DU) demonstrates that the device is as safe and effective as the current legally marketed predicate devices. . {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. SEP 3 0 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Fukuda Denshi USA, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH PA 19462-1298 Re: K082656 Trade/Device Name: FFsonic UF-750XT Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYO Dated: September 11, 2008 Received: September 12, 2008 Dear Mr. Mosenkis: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the FFsonic UF-750XT Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number FUT-CD602-5A FUT-CD602-5B FUT-CD505-8A FUT-LD386-9A FUT-CD152-5A {5}------------------------------------------------ # FUT CD105-8A FUT-TVD114-7A If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 1 other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666. Sincerely yours, Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {6}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer #### Device Name: FFsonic UF-750XT Diagnostic Ultrasound System | | | | | | Mode | of | Operation | | | | | |----------------------------------|---|---|---|-----|------|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | P | N | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | P | N | | Intraoperative | | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | P | B/M/D/C | | N | | Small Organ (specify) | | P | P | P | | P | P | P | B/M/D/C | | N | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | P | P | P | | P | P | P | B/M/D/C | P | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | P | P | P | | P | P | P | B/M/D/C | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | P | P | P | | P | P | P | B/M/D/C | | N | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | P | | P | | | | | | | N | | Musculo-skeletal<br>Superficial | | P | | P | | | | | | | N | | Other (specify) | | | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N= new indication for use; P= previously cleared by FDA; E = added under Appendix E Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Helene (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {7}------------------------------------------------ # Fill out one form for each ultrasound system or transducer #### Device Name: UF-750XT with FUT-CD602-5A #### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | Mode of Operation | | | | | | | |----------------------------------|---|---|---|-----|-------------------|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | P | N | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | P | N | | Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N= new indication for use; P= previously cleared by FDA; E = added under Appendix E Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler ( including Amplitude Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Herbert Lehman (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {8}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer ### UF-750XT with FUT-CD602-5B Device Name: | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | |-----------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | P | | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | P | | | Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Conventional | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Helena (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __ {9}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer Device Name: UF-750XT with FUT-CD505-8A | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | | |--------------------------------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | | N | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | | N | | Intraoperative | | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | P | B/M/D/C | | N | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transcsophagcal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: N == new indication for use; P= previously cleared by FDA; E = added under Appendix E Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. ----------------------------------------------------------------------------------------------------------------------------------- (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Helene (Division 6 Division of Reproductive. Abdominal and Radiological Device 510(k) Number {10}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer ### Device Name: UF-750XT with FUT-LD386-9A #### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | | | | B/M | | N | | Abdominal | | P | P | P | | | | | | | N | | Intraoperative | | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | P | B/M/D/C | | N | | Small Organ (specify) | | P | P | P | | | | | | | N | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vesscl | | P | P | P | | P | P | P | B/M/D/C | | N | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | P | | P | | | | | | | N | | Musculo-skeletal<br>Superficial | | P | | P | | | | | | | N | | Other (specify) | | | | | | | | | | | | N= new indication for use; P= previously cleared by FDA; F = added under Appendix E Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE) Hebert Leun (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {11}------------------------------------------------ # Fill out one form for cach ultrasound system or transducer ### UF-750XT with FUT-CD152-5A Device Namc: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) | | |----------------------------|-------------------------------|---|---|-----|-----|----------------------------|-------------------|------------------------|--------------------|------------------|-----------------|--| | Ophthalmic | | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | P | | | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | P | | | | Intraoperative | | | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Cardiac | | P | P | P | | P | P | P | B/M/D/C | P | | | | Transesophageal | | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | | Conventional | | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | | Superficial | | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | | N= new indication for use; | P= previously cleared by FDA; | | | | | E = added under Appendix E | | | | | | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Vclocity Doppler ) In Other mode: 3-D Imaging ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Small Organ: brcast, thyroid, testes, etc. . . . . . . (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Hubert Leever Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number {12}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer #### UF-750XT with FUT-CD105-8A Device Name: #### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | |----------------------------|---|---------------------------------|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|---------------------|--------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | | | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | | | | Intraoperative | | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | | Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | P | B/M/D/C | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | P | P | P | | P | P | P | B/M/D/C | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | P | P | P | | P | P | P | B/M/D/C | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Conventional | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | N= new indication for use: | | D -- previously classed by EDA. | | | | | C - addad under Linnandia T | | | | | = previously cleared by FDA; E = added under Appendix E Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Hubert Leem (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ {13}------------------------------------------------ ### Fill out one form for each ultrasound system or transducer ### UF-750XT with FUT-TVD114-7A Device Name: #### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | | |-------------------------------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Harmonic<br>Imaging | Other<br>(Specify) | | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | | P | P | P | B/M/D/C | | | | Abdominal | | P | P | P | | P | P | P | B/M/D/C | | | | Intraoperative | | | | | | | | | | | | | Intraoperative<br>Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | P | P | P | | P | P | P | B/M/D/C | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | P | P | P | | P | P | P | B/M/D/C | | | | Intravascular | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | | | Conventional<br>Musculo-skeletal | | | | | | | | | | | | | Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | N= new indication for use; P= previously cleared by FDA; E = added under Appendix E | | | | | | | | | | | | Other Indications or Modes: In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler ) In Other mode: 3-D Imaging Small Organ: breast, thyroid, testes, etc. (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Helenty Leem (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices, 510(k) Number