(48 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms associated with AI/ML. The description focuses on standard ultrasound technology and image acquisition.
No.
The device is used for diagnostic imaging to detect abnormalities or obstructions within vessels, not for treating them.
Yes
The device is described as obtaining a "two dimension image of the vessel structure that can be used to detect abnormalities or obstructions," which clearly indicates a diagnostic purpose.
No
The device description explicitly mentions a "catheter tip transducer" and the summary of performance studies includes "Bench and acoustic output testing" and "Bench testing, both hardware and software will undergo complete verification and validation testing," indicating the presence of hardware components.
Based on the provided information, the Galaxy Ultrasound Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Galaxy Ultrasound Imaging System uses ultrasound energy applied directly into the interior vessel wall of the patient to create images. This is an in vivo (within the living body) imaging technique, not an in vitro test on a sample.
- Intended Use: The intended use is for "ultrasound examination of intravascular pathology" and is indicated for patients undergoing "transluminal interventional procedures." This describes a diagnostic imaging procedure performed on the patient, not a laboratory test on a sample.
Therefore, the Galaxy Ultrasound Imaging System falls under the category of medical imaging devices used in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO
Device Description
The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intravascular
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)
Bench and acoustic output testing will be tested to demonstrate that the BSC Galaxy Intravascular Ultrasound Imaging System is safe and effective, while meeting the anticipated clinical requirements for its intended use. Bench testing, both hardware and software will undergo complete verification and validation testing. The BSC Galaxy Intravascular Ultrasound Imaging System will be measured and calculated per the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993).
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
APR 22 1998
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Applicant Information:
| Date Prepared: | March 3, 1998 |
|---|---|
| Name: | Boston Scientific Corporation - San Jose |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 |
Donna K. Templeman Contact Persons: Dennis L. Wong Manager, Regulatory Affairs Regulatory Affairs Associate
Telephone numbers: (408) 895-3526 or (408) 895-3607
Fax number: (408) 895-2202
Device Information:
| Classification: | Class II | |
|---|---|---|
| Trade Name: | Galaxy Intravascular Ultrasound System | |
| Common Name: | Intravascular Ultrasound Imaging System | |
| Product Code: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
Equivalent Devices:
The Galaxy Imaging System is substantially equivalent in intended use, design and / or method of operation to a combination of the following predicate devices:
-
- BSC (formerly CVIS) Insight III Imaging System (K921750) with
-
- EndoSonics In-Vision™ (Clearance number: Not available)
Special 510(k)
Galaxy Intravascular Ultrasound Imaging System
1
Intended Use:
The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
Comparison To Predicate Devices:
The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions. There are other ultrasound systems presently on the market with these intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems.
The Galaxy Imaging System is substantially equivalent in intended use, design and operation characteristics to the following devices: (1) BSC (formerly CVIS) Insight III Imaging System (K921750) (with Automatic Pullback Device (K933517) and LongView (K930311)), and (2) EndoSonics In-Vision™ (Clearance number: Not available). All predicate devices are used for ultrasound imaging of intravascular pathology in vessel anatomy.
2
Non-Clinical Tests:
Bench and acoustic output testing will be tested to demonstrate that the BSC Galaxy Intravascular Ultrasound Imaging System is safe and effective, while meeting the anticipated clinical requirements for its intended use.
Bench Testina:
Bench testing, both hardware and software will undergo complete verification and validation testing.
Acoustic Output Testing:
The BSC Galaxy Intravascular Ultrasound Imaging System will be measured and calculated per the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993), not 1997, as referenced in the FDA guidance Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997. This is a possible deviation of the acoustic output measurement methodology at Boston Scientific from the NEMA guidance documents referred to in the FDA's guidance document.
Rationale for Deviation
The FDA guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers of September 30, 1997 refers to the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA 1997), and specifically to its Section 3.3.2. However, it is our understanding that no 1997 standard has been published yet, and the most recent version of the NEMA standard that we have been able to obtain is the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1. December 7. 1993). The section 3.2.2 of this document does not reflect the wording of the 1997 FDA document and its reference to the 1997 NEMA standard regarding the low end of the frequency response of the hydrophone system (i.e., f./20). Also, the 1997 FDA quidance document states the following: "non-membrane (e.g., needle-type) hydrophones are acceptable for uses not directly affecting reporting or labeling, such as in quality control measurements" which is not reflected in the wording of the Section 3.2.2 in the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993).
Summary:
There are other ultrasound systems presently on the market with intravascular imaging capabilities. The subject BSC Galaxy Imaging System is similar in design, function, and application to these ultrasound systems and is substantially equivalent to these currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1998
Donna Templeman Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re: K980851 Galaxy Intravascular Ultrasound Imaging System Dated: March 4, 1998 Received: March 5, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Ms. Templeman:
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 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. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Galaxy Intravascular Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
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 - Donna Templeman
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 (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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
L. Elinard C. Heymann
llian Yin, Ph.D Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Galaxy Intravascular Ultrasound Imaging System Device Name:
Indication For Use:
The Galaxy Intravascular Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
K 980851
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thiel A. Segrom
(Division Sign-Off)
Division of Reproductive, Abdominal, B and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
March 4, 1998
0:91
BSC - San Jose
6
K 980851
Special 510(k)
Galaxy Intravascular Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form For Galaxy System Imaging Console
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | N | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
March 4, 1998
7
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 9F/9MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_________________
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8
Image /page/8/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K980851'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance. The contrast between the characters and the background is clear, making the sequence easily readable.
Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/40MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
9
Special 510(k) Galaxy Intravascular Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form For Discovery 2.6F/30MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
March 40199
યું ક
10
Image /page/10/Picture/0 description: The image shows the text "K980851" in a handwritten style. Below this, the text "Special 510(k)" is printed in a smaller, more formal font. The text "Galaxy Intravascular Ultrasound Imaging System" is printed below the "Special 510(k)" text.
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 3.2F/20MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ﺍ | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | P | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
11
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/20MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
Qra
Image /page/11/Picture/11 description: The image shows the text "March 4, 1998" on the top line and "0197" on the second line. The text is black and the background is white. The text is slightly blurry.
12
Diagnostic Ultrasound Indications for Use Form For Sonicath Ultra 6F/12.5MHz
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:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | 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 | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | E | ||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
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)
J
March 409989 8
13
Diagnostic Ultrasound Indications for Use Form For UltraCross 2.9F/30MHz
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:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | 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 | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | E | |||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
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)
March 4,
14
Diagnostic Ultrasound Indications for Use Form For UltraCross 3.2F/30MHz
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:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | 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 | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | E | ||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
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