PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K140639 |
|---|---|
| Device Name | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Hitachi Aloka Medical, Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 16, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications.
Device Story
Prosound F75 is a diagnostic ultrasound system consisting of a console, monitor, and various transducers. It transmits ultrasound energy into the body and detects reflected echoes to generate images and fluid flow data. Used in clinical settings (e.g., clinics, hospitals) by trained personnel (doctors, sonographers). The system processes reflected signals to display B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), and Color Doppler images. It includes advanced features like Real-time Tissue Elastography, 3D STIC, automated measurement tools (IMT, NT), and eTRACKING. Healthcare providers use these images and measurements to evaluate anatomy and blood flow, aiding in clinical diagnosis and patient management. The device benefits patients by providing non-invasive diagnostic imaging across a wide range of clinical applications.
Clinical Evidence
Bench testing only. No clinical data was required. The device was evaluated for acoustic output, biocompatibility (ISO 10993-1), cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical safety, confirming conformance to applicable standards.
Technological Characteristics
Pulsed Doppler ultrasound system. Features include B, M, PWD, CWD, and Color Doppler modes. Connectivity includes DICOM and DICOM SR. Materials tested per ISO 10993-1. Software includes automated measurement tools (IMT, NT) and image enhancement features (AIP, Spatial Compound).
Indications for Use
Indicated for diagnostic ultrasound evaluation of fetal, abdominal, intra-operative (neurosurgery), pediatric, small organ, neonatal cephalic, trans-rectal, trans-vaginal, TEE (non-cardiac), musculo-skeletal, cardiac (adult, neonatal, pediatric), peripheral vascular, and gynecological applications. Not indicated for ophthalmic applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Hitachi Prosound F75 Diagnostic Ultrasound Scanner (K123828)
Reference Devices
Related Devices
- K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM · Hitachi Aloka Medical, Ltd. · Jan 18, 2013
- K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · Feb 17, 2011
- K201693 — DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 21, 2020
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
- K212900 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 5, 2021
Submission Summary (Full Text)
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 03, 2015
Hitachi Aloka Medical, Ltd. % Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-7502
Re: K140639
Trade/Device Name: Prosound F75 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 11, 2014 Received: March 12, 2014
Dear Ms. Van Arsdale:
This letter corrects our substantially equivalent letter of April 16, 2014.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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This determination of substantial equivalence applies to the following transducers intended for use with the Prosound F75 Diagnostic Ultrasound System, as described in your premarket notification:
## Transducer Model Number
| ASU-1010 | ASU-1012 | ASU-1013 | ASU-1014 | UST-567 | UST-675P |
|---------------|------------|--------------|------------|------------|---------------|
| UST-677P | UST-678 | UST-2265-2 | UST-2266-5 | UST-5293-5 | UST-5296 |
| UST-5411 | UST-5415 | UST-5417 | UST-5418 | UST-5419 | UST-5713T |
| UST-9115-5 | UST-9118 | UST-9120 | UST-9130 | UST-9132I | UST-9132T |
| UST-9133 | UST-9135P | UST-9146I | UST-9146T | UST-9147 | UST-52105 |
| UST-52110S | UST-52114P | UST-52119S | UST-52120S | UST-52121S | UST-52124 |
| UST-52126 | UST-52127 | UST-52128 | BF UC180F | GF UCT180F | GF UC140P-AL5 |
| GF UCT140-AL5 | UST-52127 | GF UE160-AL5 | UST-52128 | TGF UC180J | BF UC180F |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jeffrey J. Ballyns -S Digitally signed by Jeffrey J. Ballyns -S DN: c=US. o=U.S. Government. ou=HHS FDA. ou=People 342.19200300.100.1.1=2000569725 ffrev J. Ballyns -S Date: 2015.03.03 14:51:22 -05'00
for
Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K140639
Device Name Prosound F75
Indications for Use (Describe)
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications.
The device is not indicated for Ophthalmic applications.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><input checked="" type="checkbox"/></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"><input type="checkbox"/></div> Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### Device Name: Hitachi Prosound F75
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | Note 1 | | |
| Fetal Imaging<br>& Other | Abdominal | P | P | P | | P | Note 1 | | |
| | Intra-operative (Specify)* | P | P | P | | P | Note 1 | | |
| | Intra-operative (Neurosurgery) | P | P | P | | P | Note 1 | | |
| | Laparoscopic** | N | N | N | | N | Note 1 | | |
| | Pediatric | P | P | P | | P | Note 1 | | |
| | Small Organ (Specify)* | P | P | P | P | P | Note 1 | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | | |
| | Trans-vaginal | P | P | P | | P | Note 1 | | |
| | TEE (non-cardiac) | P | P | P | | P | Note 1 | | |
| | Trans-esoph. (non-Card.) | P | P | P | | P | Note 1 | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Other: (Specify) * | P | P | P | | P | Note 1 | | |
| | Other: Gynecological | P | P | P | | P | Note 1 | | |
| | Cardiac Adult | P | P | P | P | P | Note 1, 2 | | |
| Cardiac | Cardiac Adult, TEE | P | P | P | P | P | Note 1, 2 | | |
| | Cardiac - Neonatal | P | P | P | P | P | Note 1, 2 | | |
| | Cardiac - Pediatric | P | P | P | P | P | Note 1, 2 | | |
| | Cardiac - Pediatric, TEE | P | P | P | P | P | Note 1, 2 | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | P | P | Note 1, 2 | | |
| | Other (spec.) | | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD
*: Specification for "Other" Airways, Tracheobronchial tree, Gastrointestinal Tract and Surrounding Organs
Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )
** Laparoscopic indication for use cleared via K110673
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 2 of 45
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Device Name: PROSOUND F75
UST-567 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | P | P | P | | P | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | P | P | Note 1 | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD * Applications: Small Organ-(breast, testes, & thyroid..)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)________________________________________________________________________________________________________________________________________________________________________
Page 3 of 45
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Device Name: PROSOUND F75
UST-675P Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)__
Page 4 of 45
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Device Name: PROSOUND F75 Transducer: UST-677P
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)
Page 5 of 45
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Device Name: PROSOUND F75 Transducer: UST-678
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)
Page 6 of 45
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Device Name: PROSOUND F75 Transducer: ASU-1010
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | Note 1 | |
| | Abdominal | P | P | P | | P | Note 1 | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | P | P | P | | P | Note 1 | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/PWD, B/CD, M/CD
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)
Page 7 of 45
{10}------------------------------------------------
Device Name: PROSOUND F75 Transducer: ASU-1012
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | N | Note 1 | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | N | Note 1 | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | P | P | P | | N | Note 1 | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)
Page 8 of 45
{11}------------------------------------------------
Device Name: PROSOUND F75 Transducer: ASU-1013
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
|--------------------------|----------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|
| | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | P | P | P | | N | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD, B/CD/ PWD
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)
Page 9 of 45
{12}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-2265-2
| Clinical Application | Mode of Operation | | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| Fetal Imaging | Abdominal | | | | | | | | |
| & Other | Intra-operative (Specify)* | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify)* | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | TEE (non-cardiac) | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Other: (Specify) * | | | | | | | | |
| | Other: Gynecological | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Adult, TEE | | | | | | | | |
| | Cardiac - Neonatal | | | | | | | | |
| | Cardiac - Pediatric | | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
Page 10 of 45
{13}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-2266-5
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | P | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
Page 11 of 45
{14}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-5293-5
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1, 2 | |
| Cardiac | Cardiac Adult, TEE | P | P | P | P | P | Note 1, 2 | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD Note 2: B/CWD, B/CD/CWD
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)________________________________________________________________________________________________________________________________________________________________________
Page 12 of 45
{15}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-5411
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | P | P | P | P | P | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Other: (Specify) * | | | | | | | |
| | Other: Gynecological | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac - Neonatal | | | | | | | |
| | Cardiac - Pediatric | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | P | P | Note 1 | |
| | Other (spec.) | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/ PWD
*Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)__
Page 13 of 45
{16}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-5415
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| Fetal Imaging | Abdominal | | | | | | | | | |
| & Other | Intra-operative (Specify)* | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify)* | P | P | P | | P | Note 1 | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | TEE (non-cardiac) | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Other: (Specify) * | | | | | | | | | |
| | Other: Gynecological | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Adult, TEE | | | | | | | | | |
| | Cardiac - Neonatal | | | | | | | | | |
| | Cardiac - Pediatric | | | | | | | | | |
| | Cardiac - Pediatric, TEE | | | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | P | | P | Note 1 | | | |
| Vessel | Other (spec.) | | | | | | | | | |
N = new indication. P = previously cleared by FDA (K123828)
Combination of each operating mode includes: Note 1: B/M, M/CD, B/CD/ PWD
Applications: Small Organ-(breast, testes, & thyroid..), Intra-operative - (liver, pancreas, gall bladder ... )
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
> (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
> > 510(k)__
Page 14 of 45
{17}------------------------------------------------
Device Name: PROSOUND F75 Transducer: UST-5417
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| Fetal Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify)* | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify)* | P | P | P | | N | Note 1 | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | TEE (non-cardiac) | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |…
