(15 days)
No
The description focuses on standard ultrasound technology and image processing without mentioning any AI/ML components or capabilities.
No.
The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also mentions it functions "as other diagnostic ultrasound devices".
No
The device description explicitly mentions hardware components like a "piezo-electric transducer," "probe cable," and "system console," which are integral to its function and are not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device description: The description clearly states that the device transmits sound waves into the body and processes the reflected waves to create images. This is an in vivo (within the living body) process, not an in vitro (in glass or outside the body) process.
- Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This further confirms its in vivo nature.
Therefore, the Aloka SSD-3500, as described, is a diagnostic imaging device that operates in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Aloka Model SSD-3500 Diagnostic Ultrasound System: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (include liver, pancreas and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (include breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Product codes
90 IYN, IYO, and ITX
Device Description
The Aloka SSD-3500 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-3500 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body: Fetal, Abdominal, Intraoperative (liver, pancreas, gall bladder), Neurological (intraoperative), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(K)
DEC 1 8 2002
510(k) Summary: Aloka Model SSD-3500 Diagnostic Ultrasound System
This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-3500 diagnostic ultrasound system and transducers. The address is:
10 Fairfield Boulevard Wallingford, CT 06492 (203) 269-5088
The contact person is: Richard J.Cehovsky, RA/QA Coordinator
The proprietary name is the Aloka SSD-3500 diagnostic ultrasound system and transducers. The common name for this type of device is a diagnostic ultrasound system and transducers.
The item in this submission is covered under the following classification:
| 90 IYN | Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 |
|---|---|---|
| 90 ITX | Diagnostic Ultrasound Transducer | 21 CFR 892.1570 |
| 90 IYO | Ultrasonic Pulsed Echo Imaging System. | 21 CFR 892.1560 |
The above as stated in 21 CFR, part 892.1570, 1560 and 1550, has been classified as regulatory Class II.
The Aloka SSD-3500 and its transducers are substantially equivalent to its predicate: the Aloka SSD-4000 and its transducers.
The Aloka SSD-3500 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-3500 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-3500, like other Aloka marketed diagnostic ultrasound systems and transducers is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-3500 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka's predicate ultrasound system: SSD-4000 (K003739) as well as Aloka's SSD-5500- (K992663).
- The SSD-3500 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound systems: SSD-4000 (K003739) and SSD-5500- (K992663).
- The SSD-3500 has the same gray-scale and Doppler abilities to Aloka's ultrasound systems: . SSD-4000 (K003739) and SSD-5500-(K992663).
1
510(k)
510(k) Summary: Aloka Model SSD-3500 Diagnostic Ultrasound System
- . The SSD-3500 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following products currently marketed by Aloka : SSD-4000 -(K003739) and SSD-5500 - (K992663).
- . The SSD-3500 has the same method of use as the following products currently marketed by Aloka: SSD-4000 - (K003739) and SSD-5500 - (K992663).
- . The SSD-3500 acoustic power output levels are below the maximum levels allowed by the FDA.
- . The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-4000 - (K003739) and SSD-5500 - (K992663).
- . The patient contact materials used in the SSD-3500 have been evaluated for safety via the same standards and methods as the above mentioned products marketed by Aloka. These materials have been found to be safe for the intended uses.
- . The SSD-3500 complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-4000 - (K003739) and SSD-5500 -(K992663).
- . Aloka Co., Ltd. Certifies that the SSD-3500 will comply with NEMA-UD2: 1992. AUM 1994 "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment". IEC-60601-1- (1990) part 1- A1&A2, UL 2601-1, 2nd edition (1997), Part 1, 2nd edition including Amendments 1&2 and ISO10993-1:1997. All testing will be complete and the results will meet the requirements of the standards above at the time of market introduction.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aloka Co .; Ltd. % Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K023996
Trade Name: Aloka Model SSD-3500 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 1YN, IYO, and ITX Dated: December 2, 2002 Received: December 3, 2002
Dear Mr. Sherratt:
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 Aloka Model SSD-3500 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
UST-995-7.5 UST-990-5
3
| UST-987-7.5 |
|---|
| UST-979-3.5 |
| UST-9104-5 |
| UST-9121 |
| UST-9123 |
| UST-9124 |
| UST-579T-7.5 |
| UST-670P-5 |
| UST-672-5/7.5 |
| UST-9101-7.5 |
| UST-5299 |
| UST-5524-7.5 |
| UST-5526L-7.5 |
| UST-5536-7.5 |
| UST-5542 |
| UST-5710-7.5 |
| UST-5268P-5 |
| UST-5293-5 |
| UST-5298 |
| UST-5546 |
| ASU-1001 |
| ASU-1003 |
| UST-9112-5 |
| UST-984-5 |
| UST-5531 |
| UST-676P |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved
4
levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David C. Bergman
for
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
4.3.1
Diagnostic Ultrasound Indications for Use Form SSD-3500
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | N | N | N | N | N | See Below | |||||
| Abdominal | N | N | N | N | N | See Below | |||||
| Intraoperative (specify) | N | N | N | N | N | See Below | |||||
| Intraoperative Neurological | N | N | N | N | N | See Below | |||||
| Pediatric | N | N | N | N | N | See Below | |||||
| Small Organ (specify) | N | N | N | N | N | See Below | |||||
| Neonatal Cephalic | N | N | N | N | N | See Below | |||||
| Adult Cephalic | N | N | N | N | N | See Below | |||||
| Cardiac | N | N | N | N | N | See Below | |||||
| Transesophageal | N | N | N | N | N | See Below | |||||
| Transrectal | N | N | N | N | N | See Below | |||||
| Transvaginal | N | N | N | N | N | See Below | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | See Below | |||||
| Laparoscopic | N | N | N | N | N | See Below | |||||
| Musculo-skeletal | |||||||||||
| Conventional | N | N | N | N | N | See Below | |||||
| Musculo-skeletal | |||||||||||
| Superficial | N | N | N | N | N | See Below | |||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD
Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
(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)
01.109)
David A. Segner
Sign-Offi
of Reproductive, Abdominal, Radiological Devi ് : (k) Number __
6
Diagnostic Ultrasound Indications for Use Form
UST-995-7.5
..
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.
(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)
301.109)
David G. Larson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K003996
20
7
Diagnostic Ultrasound Indications for Use Form UST-990-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Jamil he. Sypon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 4003999 510(k) Number _
8
Diagnostic Ultrasound Indications for Use Form
UST-987-7.5 - -
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | See Below | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder.
(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 Reproductive, Abdominal, and Radiological Devices 510(k) Number
9
UST-979-3.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | P | P | P | P | P | See Below | |||||
| Abdominal | P | P | P | P | P | See Below | |||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 229999 510(k) Number _
10
Diagnostic Ultrasound Indications for Use Form UST-9104-5 .
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | See Below | ||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices :: ('(k) Number _____________________________________________________________________________________________________________________________________________________________
11
.
UST-9121
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | P | P | P | P | P | See Below | |||||
| Abdominal | P | P | P | P | P | See Below | |||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Claird A. Sgmon
(Division Sign-Off) Division of Reproductive, Abdominal, nd Radiological Devices 2023956 ා ! "K: Number ______________________________________________________________________________________________________________________________________________________________
12
. UST-9123
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | P | P | P | P | P | See Below | |||||
| Abdominal | P | P | P | P | P | See Below | |||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel A. Lannon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
13
UST-9124 :
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David Lee Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 576 510(k) Number _
14
Diagnostic Ultrasound Indications for Use Form
UST-579T-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (O Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices : ! (^(k) Number _
15
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | See Below | |
| Transvaginal | | P | P | P | | P | P | | See Below | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
16
Diagnostic Ultrasound Indications for Use Form
UST-672-5/7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | See Below | ||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder.
(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)
David G. Lyman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
17
Diagnostic Ultrasound Indications for Use Form UST-9101-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Thompson
(Division Sign-Off) Division of Reproductive, Abdominal ് Radiological Devices . Da Nimber
18
:
Model SSD-3500
Diagnostic Ultrasound Indications for Use Form
UST-5299 ...
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Below | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Spann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
19
UST-5524-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Small parts applications include breast. testes and thyroid.
(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)
33
Edith Ingram
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices b : (i() Number ___
20
UST-5526L-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | P | P | P | P | P | See Below | ||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder.
(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)
Ymind E. Aym
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Devices 5 1 O(k) Number _
34
21
Diagnostic Ultrasound Indications for Use Form UST-5536-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | |||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | P | P | P | P | P | See Below | |||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder.
(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),
રૂદ
Elnind A. Stymm
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 5 | 3(k) Number ______________________________________________________________________________________________________________________________________________________________
22
Diagnostic Ultrasound Indications for Use Form
UST-5542
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | P | P | P | P | P | |||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | See Below | ||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | See Below | ||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Small parts applications include breast, testes and thyroid.
(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)
Tivision of Reproductive, Abdominal on Radiological Devices イン Number
Abdominal
K023996
23
Aloka Co., Ltd
Diagnostic Ultrasound Indications for Use Form
UST-5710-7.5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Small parts applications include breast, testes and thyroid.
(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)
Daniel A. Sypem
(Division Sign-Off) Division of Reproductive, Andominal mo Radiological Devices 023996 っているということです
24
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | P | P | P | P | P | See Below | ||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.
(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) Susion of Reproductive Andomi Controporal Dov
25
UST-5293-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | See Below | ||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Gavin L. Nguyen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
26
Diagnostic Ultrasound Indications for Use Form UST-5298
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | See Below | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Ymird A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0233996
40
27
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | E | E | E | E | E | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | E | E | E | E | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Elmer G. Hygum
(Division Sign-Off) Division of Reproductive. Abdomina and Radiological Devices e 94k) Nomber ...............................................................................................................................................................
28
gnostic Ultrasound Indications for l ASU-1001
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David H. Heyman
(Division Sign-Off) Division of Reproductive, Andominal and Radiological Devices 11235 14:50 April 2019 Production Program Program Program 2017 Program 2017 Program 2017 Program 2017 Program 2017 Program 2017 Program 2017 Pro 2017 Pro 2017 Pro 2017 Pro 2017 Pro
29
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Ewind A. Bergman
Division Sign-Off) ision of Reproductive 31 deat arman at The
μ02396
30
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
(01.109)
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
31
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes 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 Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Jarvis 6. belgen
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
45
32
UST-5231
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as fo
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.
Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OF Prescription Use (Per 21 CFR 801.109)
510(k)
(Division Sign-Off) Davion of Reproductive Abden and Partinary of Praire Box 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1,
33
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | E | E | E | E | E | See Below | ||||
| Transvaginal | E | E | E | E | E | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes 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 Device Evaluation (ODE Prescription Use (Per 21 CFR 801.109)
ion (ODE)
9)
(Division Sign-Off) Division of Reproductive Arand Radiological Device:
5100kj Number . ...