(3 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-850XTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-850XTD 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.
The Fukuda Denshi model UF-850 XTD is a full featured general purpose Track III diagnostic ultrasound system. The device consist of a mobile console approximately 19" wide, 31"deep and 53-57" (adjustable) high, that provides digital acquisition, processing and display capabilities. The user interface includes a keyboard, specialized controls and either a color CRT or LCD display.
The provided document is limited in the detail required to fill out all requested sections. This is common for 510(k) submissions of the time, especially for devices undergoing modifications or demonstrating substantial equivalence where extensive new clinical studies are not always required.
However, based on the information provided, here's what can be extracted and inferred:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria for a new AI/algorithm but rather focuses on comparing the modified device's performance to a predicate device. The core acceptance criterion for this 510(k) modification is substantial equivalence to the predicate device, the Fukuda Denshi model FF sonic UF-750XT Diagnostic Ultrasound System (K033209).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same fundamental technology as predicate device. | The UF-850XTD incorporates the "same fundamental technology as the predicate device." |
| Probe Equivalence: Probes are modified versions of those cleared with the predicate. | "All probes are modified version of the probes cleared with the predicate." |
| Acoustic Output Compliance: Acoustic output remains below pre-amendment upper limits (Ispta ≤ 720 mW/cm², MI ≤ 1.9 for Track 3, Non-ophthalmic). | "The Acoustic Output is measured and calculated per NEMA UD 2... The system will assure that the acoustic output will always stay below the pre-amendment upper limits..." |
| Material Biocompatibility: Patient contact materials are biocompatible and identical to the predicate device. | "All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device." |
| Safety and Efficacy Equivalence: The device is as safe, as effective, and performs as well or better than the predicate device. | "The conclusion drawn from the testing... demonstrates that this device is as safe, as effective and performs as well or better than the current legally marketed predicate device..." |
| Conformity to Applicable Standards: The device adheres to specified medical device safety standards (e.g., NEMA, EN, ISO). | Laboratory testing verified conformity to NEMA UD 2, NEMA/AIUM UD 3, EN 60601-1-1, EN 60601-1-2, EN 60601-1-2-37, ISO 10993, and ISO-14971. |
Study Details
Based on the provided document, no specific clinical study involving AI or an algorithm for diagnostic interpretation was conducted or noted. This submission is for a modification of an ultrasound system, not the clearance of an AI/ML diagnostic tool. The document explicitly states:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No test set for an AI/algorithm was described. The testing described was laboratory-based to verify design specifications and compliance with standards.
- Data Provenance: Not applicable for AI/algorithm performance. The context is system verification against design specifications and predicate device equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for an AI/algorithm test set was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 submission does not pertain to AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This submission is for a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for AI/algorithm performance. The "truth" for this submission was based on engineering design specifications, performance against known physical standards (e.g., acoustic output), and comparison to the predicate device's established performance.
8. The sample size for the training set:
- Not applicable. No training set for an AI/algorithm was described.
9. How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
FEB 1 7 2005
Fukuda Denshi Model UF-850 XTD 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 50363
| Submitter: | Fukuda Denshi U.S.A. Inc.17725 NE 65th St. Building CRedmond, WA 98052 |
|---|---|
| Tel: | 425-881-7737 |
| Fax: | 425-869-2018 |
Larry D. Walker Contact Person: Regulatory Affairs Manager Fukuda Denshi U.S.A. Inc. 17725 NE 65th St. Building C Redmond, WA 98052 Tel: 425-881-7737 425-869-2018 Fax:
Date Prepared:
| Device Name: | Fukuda Denshi model 850 XTD Diagnostic Ultrasound System |
|---|---|
| Common Name | General Purpose Ultrasound Scanner with Doppler |
| Classification: | Ultrasound Pulse Doppler Imaging System, 21 CFR 892-1550, 90IYNUltrasound Pulse Echo Imaging System, 21 CFR 892-1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892-1570, 90-ITX |
| Marketed Device: | Fukuda Denshi model FF sonic UF-750XT Diagnostic UltrasoundSystem, 510(k) No. K033209 and Fukuda Denshi model FF sonic UF-5800Ultrasound System with Doppler 510(k) K99040, currently in commercialdistribution. |
| Device Description: | The Fukuda Denshi model UF-850 XTD is a full featured general purposeTrack III diagnostic ultrasound system. The device consist of a mobileconsole approximately 19" wide, 31"deep and 53-57" (adjustable) high, thatprovides digital acquisition, processing and display capabilities. The userinterface includes a keyboard, specialized controls and either a color CRT orLCD display. |
{1}------------------------------------------------
Fukuda Denshi Model UF-850XTD Special 510(k) Device Modification Exhibit B
The device is intended to be used for applications in fetal, abdominal, Intended Use: 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-850XTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-850XTD 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 UF-850XTD incorporates the same fundamental technology as the predicate device. All probes are modified version of the probes cleared with the predicate. The device has been tested as Track 3 devices per the guidance document:" Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers" Issued September 300", 1997. The Acoustic Output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 1998. The system will assure that the acoustic output will always stay below the pre-amendment upper limits i.e. Ispta ≤720mW/cm2 and MI ≤1.9 (Track 3, Non ophthalmic) All patient contact materials are biocompatible and identical to the predicate Fukuda Denshi device.
The technology characteristics of the FF sonic UF-850XTD 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 risk management or in the system validation.
Testing: Laboratory Testing:
Laboratory testing was conducted to verify that the Fukuda Denshi model UF-850XTD met all design specification and was substantially equivalent to the currently marketed Fukuda Denshi FF sonic model UF-750XT. 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 UF-850XTD 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 Safety Standards:
- NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment: 1998
- NEMA/AIUM UD 3 Standard for Real-Time Display of Thermal . and Mechanical Acoustic Output Indices: 1998
- EN 60601-1-1:2000 Part 1: General Requirements for Safety .
- . EN 60601-1-2: 2001 Electromagnetic Compatibility
- . EN 60601-1-2-37:2001 Particular Requirements for the Safety of Ultrasound Medical Diagnostic and Monitoring Equipment.
- ISO 10993 Biocompatibility .
- ISO-14971:2000 Application of Risk Management to Medical . Devices
Clinical Test:
No clinical testing was required
- Conclusion: The conclusion drawn from the testing of the Fukuda Denshi model UF-850 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-750 XT. (510(k) No.. K033209
{3}------------------------------------------------
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry D. Walker Regulatory Affairs Manager Fukuda Denshi U.S.A., Inc. Seattle Branch 17725 N.E. 65th Street, Building C REDMOND WA 98052
Re: K050363
Trade Name: Fukuda Denshi Model UF-850XTD Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasound pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: February 10, 2005 Received: February 14, 2005
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 UF-850XTD Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
FUT-CG602-5A FUT-CG505-8A
{4}------------------------------------------------
| FUT-LG386-9A |
|---|
| FUT-LG308-16A |
| FUT-SG162-5A |
| FUT-SG125-8A |
| FUT-TVG114-7A |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulations FDA it may be subject to such additional controls: "Little 21, Parts 800 to 898. In addition, FDA can be found in the Code of Peacharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issumted or a busevice with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of any I edital statutes and regulations and using, but not limited to: registration and listing (21 comply with an the Ace STequirements) (1); good manufacturing practice requirements as set CFN Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I his device, you submit a postclearance special report. This report should contain complete the first device, you submit a posterial.ures sprements based on production line devices, requested information, mending acoused) of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (cherobod) of the Siamostic Ultrasound Systems and Transducers." If the special Secking Marketing Clearantes of Dagestable values (e.g., acoustic output greater than approved report is incomplete or comains anaovepation 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 The special report in the "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 This lotter will anon. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 If you atence 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 other general information on your responsibilities under the Act from the Division of Small
{5}------------------------------------------------
Page 3 - Mr. Walker
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Lynn
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
Device Name: UF-850XTD Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | P | B/M/D/C | P | ||
| Abdominal | P | P | P | P | P | P | P | B/M/D/C | P | ||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | B/M/D/C | |||
| Small Organ | P | P | P | P | P | P | P | B/M/D/C | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | 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 | B/M/D/C | ||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | |||||||||
| Musculo-skeletal Superficial | P | P | |||||||||
| Other (specify) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
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 ( including PWD, CWD), 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)
のお気になる。
David U. Hlynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _
{7}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-CG602-5A
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | 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 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Laparoscove | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
E = added under Appendix E N= new indication for use; P= previously cleared by FDA;
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)
David h. deyoung
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
{8}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-CG505-8A
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | HarmonicImaging | Other(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 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Com...nal | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
P= previously cleared by FDA; E = added under Appendix E N= new indication for 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 K. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological I 510(k) Numbe
{9}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-LG386-9A
| 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 | P | B/M | |||||||
| Abdominal | P | P | P | ||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | B/M/D/C | ||||
| Small Organ | P | P | P | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | P | P | P | P | P | P | B/M/D/C | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | P | P | |||||||||
| Musculo-skeletal Superficial | P | P | |||||||||
| 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:
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 )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Argeson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
{10}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-LG308-16A
| 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 | P | B/M | |||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | B/M/D/C | ||||
| Small Organ | P | P | P | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | P | P | P | P | P | P | B/M/D/C | ||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | P | P | |||||||||
| Musculo-skeletalSuperficial | P | P | |||||||||
| Other (specify) | |||||||||||
| N= new indication for use; | P= previously cleared by FDA; | E = added under Appendix F |
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------dusio of the human hads or follows: Intended Lies aund imaging o ઘનનવ વર્ષ
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)
Daniel G. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050263
Ultrasound Device Intended Use Form
{11}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-SG162-5A
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Mode of OperationColor Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Harmonic Imaging | Other (Specify) |
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P | B/M/D/C | P | ||
| Abdominal | P | P | P | P | P | P | P | B/M/D/C | P | ||
| Intraoperative | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | B/M/D/C | P | ||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Tise:
E = added under Appendix E N= new indication for use; P= previously cleared by FDA;
Other Indications or Modes:
In Combined mode: B = B mode, M = M mode, D = Doppler ( including PWD, CWD), 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. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device
510(k) Number N050363
{12}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-SG125-8A
| 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 | 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 | P | B/M/D/C | |||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | 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) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
P= previously cleared by FDA; E = added under Appendix E N= new indication for use;
Other Indications or Modes:
In Combined mode: B = B mode, M = M mode, D = Doppler ( including PWD, CWD), C = Color Doppler ( including Amplitude Doppler, Color Velocity Doppler )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dimil A. hyram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050363
{13}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: UF-850XTD with FUT-TVG114-7A
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Diagnosis | 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 | P | P | P | P | B/M/D/C | ||||
| Abdominal | P | P | P | P | P | P | B/M/D/C | ||||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | 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 | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
P= previously cleared by FDA; E = added under Appendix E N= new indication for use;
Other Indications or Modes:
In Combined mode: B = B mode, M = M mode, D = Doppler (PWD), C = Color Doppler ( including Amplitude Doppler, Golor Velocity Doppler )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David Ch. Jessup
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K050363
§ 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.