PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K123828 |
|---|---|
| Device Name | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Hitachi Aloka Medical, Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 18, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
Device Story
Prosound F75 is a mobile diagnostic ultrasound system for imaging and fluid flow analysis. It utilizes a console with a display, keyboard, and specialized controls to acquire, process, and display ultrasound data. Operated by qualified physicians in clinical settings, the system supports various transducers for diverse anatomical applications. It employs standard ultrasound imaging modes (B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler) to visualize internal structures and blood flow. The system processes acoustic signals to generate real-time images, aiding clinicians in diagnostic evaluations and clinical decision-making. The device is used for a wide range of applications, including cardiac, fetal, abdominal, and intra-operative procedures, providing diagnostic information that informs patient management and treatment planning.
Clinical Evidence
Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety. It conforms to applicable medical device safety standards. No clinical testing was required.
Technological Characteristics
Mobile ultrasound console with B, M, PWD, CWD, and Color Doppler modes. Utilizes various transducers (e.g., UST-567, UST-5293-5, etc.). Operates under Track 3 FDA limits. Materials evaluated for biocompatibility. System supports multiple clinical applications including cardiac and intra-operative imaging. Software-based processing for image acquisition and analysis.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intra-operative (including neurosurgery), pediatric, small organ, neonatal cephalic, trans-rectal, trans-vaginal, non-cardiac TEE, musculoskeletal, adult/pediatric/neonatal cardiac, peripheral vascular, and gynecological applications. Not indicated for ophthalmic use.
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
- Aloka Prosound F75 Diagnostic Ultrasound System (K110207)
- Aloka SSD-5000 V 5.0 Ultrasound System (K033311)
- Aloka SSD-5500 V6.0 Diagnostic Ultrasound System (K032875)
Reference Devices
- Olympus GF-UE160 AL5 (K051541)
- Olympus GF-UCT180 (K093395)
- Olympus BF-UC180F (K070983)
- Olympus TGF-UC180J (K093395)
Related Devices
- K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM · Aloka Co., Ltd. · Feb 17, 2011
- K140639 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM · Hitachi Aloka Medical, Ltd. · Apr 16, 2014
- K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO · Shimadzu Medical Systems · Jul 25, 2006
- K960527 — LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM · GE Medical Systems · Sep 8, 1997
- K223570 — SonoAir Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Mar 31, 2023
Submission Summary (Full Text)
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Hitachi Aloka Medical, Ltd.
## 510(k) Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92
**JAN 1 8 2013**
#### Section a):
#### 1. Submitter's contact name, address, telephone/fax number
: : : .
Angela Van Arsdale RA/OA Manager Hitachi Aloka Medical, Ltd., 10 Fairfield Boulevard Wallingford, CT 06492 Tel: (203)269-5088 Ext. 346 Fax: 203-269-6075
#### Date Prepared: 12/10/2012
| 2. Device Name: | Prosound F75 Diagnostic Ultrasound System | |
|-----------------|---------------------------------------------------|-----------------|
| | 90 IYN - Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 |
| | 90 ITX - Transducer Ultrasonic, Diagnostic | 21 CFR 892.1570 |
| | 90 IYO - Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 |
### 3. Substantially Equivalent Devices:
Aloka Prosound F75 Diagnostic Ultrasound System, (K110207), for system & probes. Aloka SSD-5000 V 5.0 Ultrasound System, (K033311), for expanded indications. Aloka SSD-5500 V6.0 Diagnostic Ultrasound System, (K032875), for expanded indications.
#### 4. Device Description:
The Prosound F75, formerly named Aloka Prosound F75, Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).
#### 5. Indications for Use:
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
#### 6. Comparison w/ Predicate Device:
The Prosound F75 with expanded indications is technically comparable and substantially equivalent to the current Aloka Prosound F75 (K110207) and to the above mentioned predicates. They are Track 3 systems that employ the same fundamental and scientific technology.
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## 510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807,92
#### Section b):
- 1. Non-clinical Tests:
No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).
The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards.
#### 2. Clinical Tests: None Required.
#### ਤੇ Conclusion:
The Hitachi-Aloka Medical, Ltd.'s Prosound F75 with expanded indications is substantially equivalent in safety and effectiveness to the predicates identified above;
- . The predicate device(s) and the Prosound F75 with expanded indications are indicated for diagnostic ultrasound imaging and fluid flow analysis,
- The predicate device(s) and the Prosound F75 with expanded indications have the same . gray scale and Doppler capabilities.
- . The predicate device(s) and the Prosound F75 with expanded indications use essentially the same technologies for imaging, Doppler functions and signal processing,
- The predicate device(s) and the Prosound F75 with expanded indications have acoustic . output levels below the Track 3 FDA limits,
- . The predicate device(s) and the Prosound F75 with expanded indications are manufactured under equivalent quality and manufacturing systems.
- . The predicate device(s) and the Prosound F75 with expanded indications are manufactured of materials equivalent bio safety. The materials have been evaluated and found to be safe for this application.
- . The predicate device(s) and the Prosound F75 with expanded indications are designed and manufactured to the same electrical and physical safety standards.
Note: The Hitachi-Aloka Medical, Ltd. Ultra-Sound System naming convention for this device can be identified as Aloka Prosound F75 or Prosound F75; both trade names reference the same device. The trade name, Aloka Prosound F75, listed within K110207 was modified to Prosound F75 prior to this premarket 510(K) submission and may be identified as "Prosound F75, formerly named Aloka Prosound F75" within the text of this submission. All the device instruction and operator manuals, advertisement and promotional materials, and labeling will identify the device as Prosound F75. The naming convention change is simply a marketing decision and not indicative of a separate device or any design modifications other than the modifications described with the body of this submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 18, 2013
Hitachi Aloka Medical, Ltd. c/o Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492
Re: K123828
Trade/Device Name: Prosound F75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, and IYO Dated: December 10, 2012 Received: December 12, 2012
Dear Ms. Arsdale:
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.
This determination of substantial equivalence applies to the Prosound F75 and the following transducers intended for use with the Prosound F75 Ultrasonic pulsed Doppler Imaging System, as described in your premarket notification:
| Transducer Model Number | | | |
|-------------------------|------------|----------------|-------------|
| UST-567 | UST-5293-5 | UST-9130 | UST-52114P |
| UST-675P | UST-5411 | UST-9132 I & T | UST-52119S |
| UST-677P | UST-5415 | UST-9133 | UST-52121S |
| UST-678 | UST-5417 | UST-9135P | UST-52124 |
| ASU-1010 | UST-5419 | UST-9146 I & T | GF-UE160 AL |
| ASU-1012 | UST-5713T | UST-9147 | GF-UCT180 |
| ASU-1013 | UST-9115-5 | UST-52105 | BF-UC180F |
| UST-2265-2 | UST-9118 | UST-52110S | TGF-UC180 |
| UST-2266-5 | UST-9120 | UST-52120S | |
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance, 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
## Sean M. Boyd -S for
Janine Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Hitachi Aloka Medical, Ltd.
## Indications for Use
510(K) Number (if known):
Device Name:
Prosound F75
Indications For Use:
The device is intended for use by a qualified physician for ultrasound Fetal; evaluation of Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal: TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
# Concurrence of CDRH, Office of Device Evaluation Sean M. Boyd (Division Sign Off Division of Radiological He f In Vitro Diagnostics and Pit
### Page 1 of 1
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#### System: 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 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | P | P | P | | P | Note 1 | |
| | Abdominal | P | P | P | | P | Note 1 | |
| | Intra-operative (Specify)* | P | P | P | | P | Note 1 | |
| | Intra-operative (Neurosurgery) | N | N | N | | N | Note 1 | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | | |
| | Small Organ (Specify)* | P | P | P | N | P | Note 1,2 | |
| | 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) | N | N | N | | N | Note 1 | |
| | Musculo-skeletal (Convent.) | P | P | P | | P | Note 1 | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| Cardiac | Cardiac, Adult | P | P | P | P | P | Note 1, 2 | |
| | Cardiac Adult, TEE | N | N | N | N | N | Note 1, 2 | |
| | Cardiac- Neonatal | N | N | N | N | N | Note 1, 2 | |
| | Cardiac- Pediatric | N | N | N | N | N | Note 1, 2 | |
| | Cardiac Pediatric, TEE | N | N | N | N | N | Note 1, 2 | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | N | P | Note 1,2 | |
| | Other: Gynecological | P | P | P | | P | Note 1 | |
Intended Use: Diggnostic ultrasound im
N = new indication; P= previously cleared by FDA-(K110207); E=added under Appendix E
Combination of each operating mode includes: Note 1: BM, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD
Note 3: Specification for "Other" Airways, Tracheobronchial tree, Gastrointestinal Tract and Surrounding Organs * Applications: Small Parts - (breast, testes, & thyroid...), Intra-operative - (liver, pancreas, gall bladder ...)
Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiology
510(k) K123828
{6}------------------------------------------------
System: Prosound F75 Transducer: UST-567
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|-----------------------------------|---|-------------------|-----|-----|------------------|-----------------------|--------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| Fetal Imaging<br>& Other | Small Organ (Specify)* | P | P | P | | P | See note 1 | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | | |
| | Musculo-skeletal (Convent.) | P | P | P | | P | See note 1 | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | P | P | P | | P | See note 1 | | |
| | Other: Gynecological | | | | | | | | |
P= previously cleared by FDA-(K110207)
Combination of each operating mode includes: Note 1: BM, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD * Applications: Small Parts - (breast, testes, & thyroid...), Intra-operative - (liver, pancreas, gall bladder ... ) Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Prescription Use (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
510(k) K123828
{7}------------------------------------------------
#### System: Prosound F75 Transducer: UST-675P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Clinical Application | Mode of Operation | | | | | | |
|---------------------------|-----------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging | Small Organ (Specify) | | | | | | | |
| & Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | See note 1 | |
| | Trans-vaginal | P | P | P | | P | See note 1 | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | |
| Vessel | Other: Gynecological | | | | | | | |
P= previously cleared by FDA- (K110207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109)
Sean M. Boyd -
(Division Sign Off)
Division of Radiological Health
510(k) K123828
{8}------------------------------------------------
.
## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: 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 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | E | E | E | | E | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other: Gynecological | | | | | | | |
E=added under Appendix E
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Pe
Sean M. Boyd -S
(Division Sign Off)
Division of Radiological Health
s10(K123828
{9}------------------------------------------------
#### System: 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 1 Only) | Specific<br>(Tracks 1 & 3) | 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 | E | E | E | | E | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other: Gynecological | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E=added under Appendix E
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Sean M. Boyd -S
(Division Sign Off)
റ്റിഗ് of Radiological Health
วาน(k) K123828
{10}------------------------------------------------
#### System: 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 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | Note 1 | |
| | Abdominal | P | P | P | | P | Note 1 | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other: Gynecological | P | P | P | | P | Note 1 | |
P= previously cleared by FDA- (K110207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
## Sean M. Boyd -
(Division Sign Off)
Division of Radiological Health
510(k) K123828
{11}------------------------------------------------
#### System: 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 | Specific | B | M | PWD | CWD | Color | Combined | Other | | |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | Doppler | (Specify) | (Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | E | E | E | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| Fetal Imaging | Small Organ (Specify) | | | | | | | | | |
| & Other | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | E | E | E | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | |
| | (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | | | |
| Vessel | Other: Gynecological | E | E | E | | | | | | |
E=added under Appendix E
Combination of each operating mode includes: Note : B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
## Sean M. Boyd -S
#### (Division Sign Off)
#### Division of Radiological Health
51000 K123828
{12}------------------------------------------------
#### System: Prosound F75 Transducer: ASU-1013
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|-----------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | 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) | E | E | E | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other: Gynecological | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
E=added under Appendix E
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
### Prescription Use (Per 21 CFR 801.109) ean M
## (Division Sign Off)
Division of Radiological Health
Office of In vitro Ulagnostics and Rad
510(k) K123828
{13}------------------------------------------------
.
.
## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Prosound F75 Transducer: UST-2265-2
| | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
|---------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|-----------------------|--------------------|
| | Clinical Application | | Mode of Operation | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | 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 | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Adult, TEE | | | | | | | |
| | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | | | | | |
| | Other :Gynecological | | | | | | | |
N = new indication; P= previously cleared by FDA- (K110207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other:
> (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
## ean IV
(Division Sign Off)
Division of Radiological Heatth
510(k) K123828
{14}------------------------------------------------
System: Prosound F75 Transducer: UST-2266-5
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | | |
|--|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| | | company of collection of confidence of the driver of the driver of the driver of | |
| Clinical Application | | | Mode of Operation | | | | | |
|------------------------------|--------------------------------|---|-------------------|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Cardiac Adult | | | | P | | | |
| | Cardiac Adult, TEE | | | | | | | |
| Cardiac | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral Vascular | | | | P | | | |
| Vessel | Other : Gynecological | | | | | | | |
P= previously cleared by FDA- (K110207)
Combination of each operating mode includes: Note 1: B/M, B/PWD, M/CD, B/CD/PWD Note 2: B/CWD, B/CD/CWD Other :
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 C
## sean M
(Division Sign Off)
Division of Radiological Health
510(k) K123828
{15}------------------------------------------------
System: 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 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | TEE (non-Cardiac) | | | | | | | |
| | Musculo-skeletal (Convent.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1, 2 | |
| | Cardiac Adult, TEE | N | N | N | N | N | Note 1, 2 | |
| Cardiac | Cardiac- Neonatal | | | | | | | |
| | Cardiac Pediatric, TEE | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vascular | | | |…
