(28 days)
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-750XT incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The FF sonic UF-750XT 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (Specify), Cardiac, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (Specify), Harmonic Imaging.
Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )
The Fukuda Denshi model FF sonic UF- 750XT is a compact and portable general-purpose diagnostic ultrasound scanner with a fold down keyboard, integrated 10.4 inch TFT color LCD display and interchangeable convex and linear transducers. The system has physical dimensions 380 mm W X 220 mm D X 370 mm H in transport configuration. The system provides data acquisition, processing and display capabilities. User interfaces include the drop down computer type keyboard which includes specialized controls, Doppler audio and a color LCD display.
The Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System is a modification of a previously cleared device, the Fukuda Denshi model FF sonic UF-5800. The submission focuses on demonstrating substantial equivalence to the predicate device, rather than defining new performance metrics or conducting clinical trials to establish new acceptance criteria.
Therefore, the "acceptance criteria" for this device are aligned with ensuring it meets safety standards and performs comparably to the predicate device for its intended uses.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (derived from document) | Reported Device Performance |
|---|---|---|
| Predicate Equivalence | The device must be substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800. This implies comparable technological characteristics, safety, and effectiveness. | The FF sonic UF-750XT incorporates the same fundamental technology as the predicate device. All probes are modified versions of the probes cleared with the predicate. The technology characteristics do not affect safety or efficacy. The device "was substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800." |
| Safety Standards | Conformance to applicable medical device safety standards for thermal, mechanical, and electrical safety, as well as biocompatibility and effectiveness of cleaning and disinfection. Specific standards mentioned include: NEMA UD 2, NEMA UD 3, IEC 60601-1-1, IEC 60601-1-2. | 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." It "conforms to the following Standards: NEMA UD 2, NEMA UD 3, IEC 60601-1-1, IEC 60601-1-2." |
| Acoustic Output | Acoustic output must be measured and calculated per NEMA UD 2 (1998). All transducer/system combinations must not exceed a Thermal or Mechanical Index of 1.0. | Acoustic Output is measured and calculated per NEMA UD 2 (1998). All transducers are track 3 transducers, and testing validated that "no transducer/system combination exceeded a Thermal or Mechanical Index of 1.0." |
| Biocompatibility | All patient contact materials must be biocompatible. | "All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device." |
| Intended Use | The device should be safely usable for the specified clinical applications (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal) and modes of operation (B, M, PWD, Color Doppler, etc.). Any new indications (N) for specific transducers should be acceptable. | The intended use applications include fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, and musculo-skeletal. The forms for each transducer indicate "P" (previously cleared by FDA) for most applications and modes, with "N" (new indication for use) specifically for PWD (Pulsed Wave Doppler) mode for several applications across multiple transducers (e.g., Fetal, Abdominal, Pediatric, Small Organ - where applicable, Cardiac, Peripheral Vessel, Transvaginal - where applicable). This indicates that the device's performance for these "new" modalities on existing applications was assessed as acceptable. |
| Software Controlled Device | Any safety issues raised by a software controlled medical device should either be the same as those addressed by the predicate or addressed in the system hazard analysis or system validation. | "Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or are addressed in the system hazard analysis or in the system validation." |
Study Proving Acceptance Criteria is Met:
The study that proves the device meets these acceptance criteria is primarily a laboratory testing and design review process comparing the modified device to its predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of patient data or clinical images for testing. The testing described is primarily bench testing of the device's hardware, software, and acoustic output.
- Data Provenance: Not applicable as clinical data or patient images were not used for the testing described in this document. The comparison is against the predicate device's established technological characteristics and safety profile.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, was not required or established for this submission. The "ground truth" was adherence to engineering and safety standards and demonstration of technological equivalence to the predicate.
- Qualifications of Experts: Not applicable. Testing was conducted by engineers and technicians, likely within Fukuda Denshi, to verify technical specifications.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no clinical data requiring expert adjudication to establish ground truth.
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:
- No MRMC study was done. This is a 510(k) for a hardware modification of an ultrasound system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No standalone algorithm performance study was done. This device is an ultrasound system and does not feature a standalone diagnostic algorithm in the context of AI.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission was based on:
- Engineering specifications and measurements: Verifying output parameters, electrical safety, mechanical safety, thermal performance, and acoustic output against established standards (NEMA, IEC).
- Predicate device characteristics: The UF-5800's proven safety and effectiveness served as the benchmark. The modified device's components and underlying technology were compared to the predicate.
- Biocompatibility statements: Validation that materials meet biocompatibility requirements.
8. The Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of machine learning or AI as this is a hardware device modification submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set was used, no ground truth for a training set was established.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Fukuda Denshi. The logo consists of a stylized letter "F" on the left, followed by the words "FUKUDA" on the top line and "DENSHI" on the bottom line. The text is in a bold, sans-serif font.
OCT 3 1 2003
Fukuda Denshi Model FF sonic UF-750 XT Special 510(k) Device Modification
Exhibit B Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92
The assigned 510(k) number is: K 033209
- Fukuda Denshi U.S.A. Inc. Submitter: 17725 NE 65th St. Building C Redmond. WA 98052 425-881-7737 Tel: 425-869-2018 Fax:
- Contact Person: Larry D. Walker Regulatory Affairs Manager Fukuda Denshi - Seattle Branch 17725 NE 65th St. Building C Redmond. WA 98052 425-881-7737 Tel: Fax: 425-869-2018
- Date Prepared: September 29, 2003
- Fukuda Denshi model FF sonic UF-750 XT Diagnostic Ultrasound System Device Name:
Common Name General Purpose Ultrasound Scanner with Doppler
Ultrasound Pulse Doppler Imaging System, 21 CFR 892-1550, 90IYN Classification: Ultrasound Pulse Echo Imaging System, 21 CFR 892-1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892-1570, 90-ITX
Marketed Device: Fukuda Denshi model FF sonic UF-5800 General Purpose Ultrasound Scanner with Doppler, 510(k) No. K990401 currently in commercial distribution.
The Fukuda Denshi model FF sonic UF- 750XT is a compact and portable Device Description: general-purpose diagnostic ultrasound scanner with a fold down keyboard, integrated 10.4 inch TFT color LCD display and interchangeable convex and linear transducers. The system has physical dimensions 380 mm W X 220 mm D X 370 mm H in transport configuration. The system provides data acquisition, processing and display capabilities. User interfaces include the drop down computer type keyboard which includes specialized controls, Doppler audio and a color LCD display.
9/29/03
{1}------------------------------------------------
Fukuda Denshi Model FF sonic UF-750XT Special 510(k) Device Modification Exhibit B
Intended Use: The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-750XT incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The FF sonic UF-750XT 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 incorporates the same fundamental technology as the predicate device. All probes are modified version of the probes cleared with the predicate. The devices has been tested as a Track 3 devices per the guidance document:" Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers" Issued September 3000, 1997. The Acoustic Output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998. All transducers used with the 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 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 are 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 met all design specification and was substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-5800. 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.
{2}------------------------------------------------
Fukuda Denshi Model FF sonic UF-750XT Special 510(k) Device Modification
Exhibit B
Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment (AUIM 1998)
Applicable Standards
The Fukuda Denshi Model FF sonic UF-750XT conforms to the following Standards: NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998 NEMA UD 3 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices: 1998 IEC 60601-1-1 IEC 60601-1-2
Clinical Test:
No clinical testing was required
Conclusion: The conclusion drawn from the testing of the Fukuda Denshi FF sonic model UF-750 XT Diagnostic Ultrasound system demonstrates that this device is as safe, as effective and performs as well or better than the current legally marketed predicate device, the Fukuda Denshi model UF-5800. (510(k) No. K990401)
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
OCT 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry D. Walker Regulatory Affairs Manager Fukuda Denshi U.S.A., Inc. 17725 NE 65th St., Building C REDMOND WA 98052
Re: K033209
Trade Name: Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 30, 2003 Received: October 3, 2003
Dear Mr. Walker:
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 Fukuda Denshi Model FF sonic UF-750 XT Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| FUT-CD602-5A |
|---|
| FUT-CD505-8A |
| FUT-LD386-9A |
{4}------------------------------------------------
FUT-CD152-5A FUT-CD105-8A FUT-TVD114-7A
If vour 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer
{5}------------------------------------------------
Page 3 – Mr. Walker
Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Lyon
Nancy C. Brogdon 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
FF sonic UF-750XT Diagnostic Ultrasound System 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | N | |||
| Abdominal | P | P | N | N | N | N | B/M/D/C | N | |||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | N | N | N | N | B/M/D/C | ||||
| Small Organ(Specify) | P | P | N | N | N | N | B/M/D/C | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | N | N | N | B/M/D/C | N | |||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | P | P | N | N | N | N | B/M/D/C | ||||
| Intravascular | |||||||||||
| Peripheral Vessel | P | P | P | N | N | N | B/M/D/C | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | N | |||||||||
| Musculo-skeletalSuperficial | P | N | |||||||||
| Other (specify) | |||||||||||
| N= new indication for use; | P= previously cleared by FDA; | E = added under Appendix E |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
Small Organ is defined as thyroid, breast and testes. 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 )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use ✓
1,000
David h. Glynn
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
{7}------------------------------------------------
Fill out one form for each ultrasound system or transducer
UF-750XT with FUT-CD602-5A 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | N | |||
| Abdominal | P | P | N | N | N | N | B/M/D/C | N | |||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
P= previously cleared by FDA; N= new indication for use; 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 )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use ✓
David A. Hayes
(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-CD505-8A 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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | ||||
| Abdominal | P | P | N | N | N | N | B/M/D/C | ||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | N | N | N | N | B/M/D/C | ||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| 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 |
ostic 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 Velocity Doppler )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
David A. Legum
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
{9}------------------------------------------------
Fill out one form for each ultrasound system or transducer
UF-750XT with FUT-LD386-9A Device Name:
| Clinical Application | A | B | M | PWD | CWD | Mode of Operation | Combined(Specify) | HarmonicImaging | Other(Specify) | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | |||||||||
| Ophthalmic | |||||||||||
| Fetal | P | P | N | B/M | |||||||
| Abdominal | P | P | N | ||||||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | N | N | N | N | B/M/D/C | ||||
| Small Organ(Specify) | P | P | N | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | P | P | N | N | N | N | B/M/D/C | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | N | |||||||||
| Musculo-skeletalSuperficial | P | N | |||||||||
| Other (specify) |
Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
David R. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use
✓
{10}------------------------------------------------
Fill out one form for each ultrasound system or transducer
UF-750XT with FUT-CD152-5A Device Name:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | ||||||||||
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) | |
| Ophthalmic | N | B/M/D/C | N | ||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | N | |||
| Abdominal | P | P | N | N | N | N | B/M/D/C | N | |||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | N | N | N | B/M/D/C | N | |||
| 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 |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: ntended 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 )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __
Prescription Use ✓
{11}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-750XT with FUT-CD105-8A
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | ||||
| Abdominal | P | P | N | N | N | N | B/M/D/C | ||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | N | N | N | N | B/M/D/C | ||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | N | N | N | B/M/D/C | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | P | P | P | N | N | N | B/M/D/C | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) | |||||||||||
| N= new indication for use:P= previously cleared by FDA:E = added under Appendix E |
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 )
の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)
V Prescription Use______________________________________________________________________________________________________________________________________________________________
David A. Seppam
(Division 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-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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | N | N | N | N | B/M/D/C | ||||
| Abdominal | P | P | N | N | N | N | B/M/D/C | ||||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(Specify) | P | P | N | N | N | N | B/M/D/C | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | P | P | N | N | N | N | B/M/D/C | ||||
| 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 |
Other Indications or Modes: Small Organ is defined as thyroid, breast and testes. In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
✓
Prescription Use
David A. Layton
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 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.