(84 days)
Not Found
No
The provided text does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML in medical imaging.
No
The device is described as an "ultrasound imaging system" intended for "diagnostic imaging," explicitly stating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used by a physician for diagnostic imaging."
No
The device is described as an "Ultrasound Imaging System," which inherently includes hardware components (transducer, processing unit, display, etc.) necessary for generating and displaying ultrasound images. The summary does not indicate it is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states this is an "Ultrasound Imaging System" and its intended use is for "diagnostic imaging" of various parts of the human body. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal structures within the body.
The information provided focuses entirely on imaging the body directly, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
90IYN; 90IYO
Device Description
The AU6 is an ultrasound imaging system. Key characteristics include:
Transducer Types: Annular Array, Mechanical Sector, Linear, Convex, Phased Array, 1.5D
2D Freq MHz: 2.5/15
PW Freq MHz: 2.25/15
CW Freq MHz: 2.25/10
1.5 D: 3.5/10
Imaging Modes: Real-time/2D, M Mode, PW Doppler, CW Doppler, CFM Doppler, Power Doppler, Triplex
Probes MHz: Annular Array (20), Linear (5.0-10.0), Convex (3.5-5.0), Phased Array (2.5-10), 1.5 D (3.5-10)
Multifrequency probes: Yes
Special probes: IVT transvaginal, TRT transrectal, TEE transesophageal, LP laparoscopic, IOE intraoperative
Biopsy attachments: Convex, Linear
Monitor size (inches): 15
Programmability: 10 presets
Pulsed/CW Doppler: Yes
HIPRF: Yes
2D Updating: Yes
CW steerable: Yes
Audio stereo: Yes
Color Doppler upgrade: Yes
ECG: Option
Interconnectivity: YES
DSM integrated: YES
The device includes the following transducers:
CA11, IOE13A, LA13A, LP13A, IVT22, TRT12, SMA50, PA11B, TEE 22, PT10A, P10A
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Abdominal, Peripheral vessel, Fetal, Intraoperative (Abdominal, Peripheral vascular), Small Organ (thyroid, testicles, breast), Neonatal Cephalic, Adult Cephalic, Transesophageal, Transrectal, Transvaginal, Urological/Urinary tract, Laparoscopic, Musculo-skeletal (Conventional, Superficial). Ophthalmic is explicitly excluded. Pediatric is excluded from the first table but not specifically marked as such in the second.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
4/30/99
510(k) Summary AU6 Biosound Esaote
K99D360
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
Colleen Hittle, Official Correspondent
8000 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916 |
|---|---|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
| Date: | February 3, 1999 |
| 807.92(a)(2) | |
| Trade Name: | AU6 |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | System, Imaging, Pulsed Doppler, Ultrasonic |
| Classification Number: | 90IYN; 90IYO |
| 807.92(a)(3) |
Predicate Device(s)
| Esaote | AU5 | K980468 |
|---|---|---|
| -------- | ----- | --------- |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
510(k) Summary AU6 Biosound Esaote
807.92(a)(5)
Intended Use(s)
The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.
2
| General Characteristics | Esaote | Esaote |
|---|---|---|
| AU5 (K#980468) | AU6 Digital | |
| Transducer Type | Annular Array | Annular Array |
| Mechanical Sector | Mechanical Sector | |
| Linear | Linear | |
| Convex | Convex | |
| Phased Array | Phased Array | |
| NO | 1.5D | |
| 2D Freq MHz | 2.5/15 | 2.5/15 |
| PW Freq MHz | 2.25/10 | 2.25/15 |
| CW Freq MHz | 2.25/5.0 | 2.25/10 |
| 1.5 D | NO | 3.5/10 |
| Imaging Modes | Real-time/2D | Real-time/2D |
| M Mode | M Mode | |
| PW Doppler | PW Doppler | |
| CW Doppler | CW Doppler | |
| CFM Doppler | CFM Doppler | |
| Power Doppler | Power Doppler | |
| Triplex | Triplex | |
| Probes MHz | ||
| Annular Array | 10-20 | 20 |
| Linear | 5.0-13 | 5.0-10.0 |
| Convex | 3.5-7.5 | 3.5-5.0 |
| Phased Array | 2.5-3.5 | 2.5-10 |
| 1.5 D | NO | 3.5-10 |
| Multifreqency probes | Yes | Yes |
| Special probes | IVT transvaginal | IVT transvaginal |
| TRT transrectal | TRT transrectal | |
| TEE transesophageal | ||
| LP laparoscopic | LP laparoscopic | |
| IOE intraoperative | IOE intraoperative | |
| Biopsy attachments | Convex | Convex |
| Linear | Linear | |
| Monitor size (inches) | 14 | 15 |
| Programmability | 6 presets | 10 presets |
| Pulsed/CW Doppler | Yes | Yes |
| HIPRF | No | Yes |
| 2D Updating | Yes | Yes |
| CW steerable | Yes | Yes |
| Audio stereo | Yes | Yes |
| Color Doppler upgrade | Yes | Yes |
| ECG | Option | Option |
| Interconnectivity | NO | YES |
| DSM integrated | YES | YES |
540 mm
690 mm
-height
-depth
Comparison Chart for Substantial Equivalence
1440 mm 1100 mm Page 5
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
Colleen J. Hittle The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250
Re: K990360 AU6 Diagnostic Ultrasound System Dated: April 9, 1999 Received: April 9, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN
Dear Ms. Hittle:
We have reviewed your Section 510(k) 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 AU6 Diagnostic Ultrasound System as described in your premarket notification:
| Transducer Model Number | |
|---|---|
| CA11 | IOE13A |
| LA13A | LP13A |
| IVT22 | TRT12 |
| SMA50 | PA11B |
| TEE 22 | PT10A |
| P10A |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page -2 - Ms. Hittle:
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".
5
Page -- 3 -- Ms. Hittle
If you have any questions regarding the content of this letter, please contact Rodrigo Perez at (301) 594-1212.
Sincerely yours,
David A. Segerson
for
CAPT Daniel B. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| Clinical Application | A | B | M | PWD | CWD | Mode of Operation | | | Combined
(specify) | Other
(specify) | | | | | | | Mode of Operation | | | | |
|-------------------------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------|-----------------------|--------------------|----------------------------------|---|---|---|-----|-----|-------------------------|----------------------------|------------------------------|-----------------------|--|
| | | | | | | Color Doppler CFM | Amplitude Doppler PD | Color Velocity Imaging | | | Clinical
Application | A | B | M | PWD | CWD | Color
Doppler
CFM | Amplitude
Doppler
PD | Color
Velocity
Imaging | Combined
(specify) | |
| Ophthalmic | N | N | N | N | N | N | | | | | Ophthalmic | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | | | | | Fetal | | P | P | P | | P | P | | See
comments | |
| Abdominal | N | N | N | N | N | N | | | See comments | | Abdominal | | P | P | P | | P | P | | See
comments | |
| Intraoperative (specify)
Abdominal | N | N | N | N | N | N | | | See comments | | Intraoperative
(specify) | | | | | | | | | | |
| Intraoperative (specify)
Peripheral vascular | N | N | N | N | N | N | | | See comments | | Intraoperative
Neurological | | | | | | | | | | |
| Intraoperative
Neurological | N | N | N | N | N | N | | | See comments | | Pediatric | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | | | See comments | | Small Organ
(specify) | | | | | | | | | | |
| Small Organ (specify) | N | N | N | N | N | N | | | See comments | | Neonatal
Cephalic | | P | P | P | | P | P | | See
comments | |
| Neonatal Cephalic | N | N | N | N | N | N | | | See comments | | Adult Cephalic | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | | | See comments | | Cardiac | | | | | | | | | | |
| Cardiac | N | N | N | N | N | N | | | See comments | | Tranesophageal | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | | | See comments | | Transrectal | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | | | See comments | | Transvaginal | | | | | | | | | | |
| Transvaginal | N | N | N | N | N | N | | | See comments | | Transurethral | | | | | | | | | | |
| Transurethral | N | N | N | N | N | N | | | See comments | | Intravascular | | | | | | | | | | |
| Intravascular | N | N | N | N | N | N | | | See comments | | Peripheral
Vascular | | P | P | P | | P | P | | See
comments | |
| Peripheral
Vascular | N | N | N | N | N | N | | | See comments | | Laparoscopic | | | | | | | | | | |
| Laparoscopic | N | N | N | N | N | N | | | See comments | | Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Conventional | N | N | N | N | N | N | | | See comments | | Musculo-skeletal
Superficial | | | | | | | | | | |
| Musculo-skeletal
Superficial | N | N | N | N | N | N | | | See comments | | Other | | | | | | | | | | |
| Other - Urological | N | N | N | N | N | N | | | See comments | | | | | | | | | | | | |
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7
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David le. Glavon Prescription Use __
(Per 21 CFR 801.109)
8
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Combined (specify) | Other (specify) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler CFM | Amplitude Doppler PD | Color Velocity Imaging | ||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) Abdominal | P | P | P | P | P | See comments | |||||
| Intraoperative (specify) Peripheral vascular | E | E | E | E | E | See comments | |||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | E | E | E | E | E | See comments | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | See comments | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Peripheral vascular | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | P | P | P | P | P | P | See | ||||
| comments | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | E | E | E | E | E | See | |||||
| comments | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | P | P | P | P | P | See | |||||
| comments | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify | |||||||||||
| ) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | See | |||||
| comments | |||||||||||
| Transvaginal | N | N | N | N | N | See | |||||
| comments | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other-Urological | N | N | N | N | N | See | |||||
| comments | |||||||||||
| Mode of Operation | |||||||||||
| Clinical | |||||||||||
| Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | E | E | E | E | E | See | |||||
| comments | |||||||||||
| Transvaginal | P | P | P | P | P | See | |||||
| comments | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other-Urological | N | N | N | N | N | See | |||||
| comments | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | P | P | See | ||||||||
| comments | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | E | E | See | ||||||||
| comments | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | N | N | N | N | N | N | See | ||||
| comments | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | See | ||||
| comments | |||||||||||
| Adult Cephalic | N | N | N | N | N | N | See | ||||
| comments | |||||||||||
| Cardiac | N | N | N | N | N | N | See | ||||
| comments | |||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Tranesophageal | N | N | N | N | N | N | See | ||||
| Comments | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | ||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | E | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Mode of Operation | |||||||||||
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | |||||||||||
| CFM | Amplitude | ||||||||||
| Doppler | |||||||||||
| PD | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | ||||||||||
| Tranesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral | |||||||||||
| Vascular | E | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other |
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Small organs (specifically, thyroid, testicles and breast; Peripheral vascular to include Vein Mapping & Scierotherapy
Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801.109) | Concurrence of CDRH, Office of Device Evaluation (ODE) | K990360 |
|---|---|---|
| ------------------------------------------ | -------------------------------------------------------- | --------- |
14
9
AppendixF
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Small Organs (specifically, thyroid, testicles, and beast): Peripheral Vascular to include. Vein Mapping &
Sclerotheragy
Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | K990360 |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) |
15
10
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
૧૯
11
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Applicable combined modes: B+PW+CFM+M+PD
(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) |
Lezama
12
Appendix F
TRT12
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Applicable combined modes: B+PW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 90360
i
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
13
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Small Organs (specifically, thyroid testicles, and beast): Perigheral vascular to include Yein Mapping & 2018/08/19997
Applicable combined modes: B + M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Preser (Per 21 CFF R 801.109)
David A. Szezin 19
14
PA11B
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: : Applicable combined modes: B+PW+CW+CFM+M+PD
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
DE) K990360
- Quind C. Segerson
escription ofe
21 CFR 801.109)
15
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Applicable combined modes: B+PW+CFM+M+PD+CW
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K99036D
Prescription Use
(Per 21 CFR 801.109) ✓
Daniel A. Szyrm
16
PT10A
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE) K990360
cription Use
21 CFR 801.109)
22
17
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
23