(17 days)
The Site-Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intraoperative (semi-critical†) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric) Typical examinations performed using the Site-Rite Vision™ Ultrasound System include: Vascular Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterial line placement, and peripheral vein and artery access Abdominal Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures Interventional and Intraoperative Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi-critical†) Superficial Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculo-skeletal procedures, soft tissue structures, and surrounding anatomical structures
Not Found
This document describes the Site-Rite Vision™ Ultrasound System and its indications for use. It's a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical trials. Therefore, a study proving the device meets acceptance criteria as typically understood for a new diagnostic or AI-driven aid is not included.
Based on the provided text, the "acceptance criteria" here refer to the range of clinical applications and imaging modes for which the device is cleared, and its performance is considered substantially equivalent to existing, legally marketed ultrasound systems.
Here's the information extracted from the document, tailored to your request about acceptance criteria and study data where applicable within the context of a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound system, the "acceptance criteria" are the broad range of clinical indications and imaging modes for which the device is deemed safe and effective, based on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions comparably to these predicate devices for the listed applications.
| Clinical Application / Probe | Mode of Operation (Reported Performance - Cleared) |
|---|---|
| All Probes (System General) | B, Color Doppler (CD), Combined (B+CD) for various applications |
| Fetal | B+CD |
| Abdominal | B+CD |
| Intra-operative (semi-critical) | B+CD |
| Pediatric | B+CD |
| Peripheral Vessel Size Guide for use with relevant probe | B+CD |
| Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) | B+CD (for 128 Element Linear Probes), N/A (for Convex Probe) |
| Musculo-skeletal (Conventional) | B+CD |
| Musculo-skeletal (Superficial) | B+CD (for 128 Element Linear Probes), N/A (for Convex Probe) |
| Cardiac Adult | B+CD |
| Cardiac Pediatric | B+CD |
| Peripheral Vessel (general) | B+CD |
Note: The "N" in the tables indicates a "new indication" for the specific predicate device comparison, implying that while it might not have been on that specific predicate, it is being cleared based on substantial equivalence within the broader class of ultrasound devices for these applications. The "P" (previously cleared by FDA) and "E" (added under this appendix) are not explicitly marked for individual modes in the provided tables, but are mentioned in the legend.
2. Sample Size Used for the Test Set and Data Provenance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It does not present a clinical study with a "test set" in the sense of a new clinical trial designed to evaluate specific numerical performance metrics (e.g., sensitivity, specificity, accuracy). Therefore, there is:
- No specified sample size for a test set.
- No data provenance (country of origin, retrospective/prospective) for a performance study, as such a study is not detailed here. The submission relies on existing knowledge and performance of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no new clinical study with a "test set" requiring ground truth establishment is detailed here, this information is not applicable (N/A) to this 510(k) submission.
4. Adjudication Method for the Test Set
As no "test set" and corresponding ground truth establishment is described, an adjudication method is not applicable (N/A).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or detailed in this 510(k) summary. This type of study would typically be conducted to evaluate the improvement in human reader performance with or without AI assistance, which is outside the scope of this ultrasound system's 510(k) submission, as it is a device for direct imaging, not an AI-assisted diagnostic algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone performance study of an algorithm without human-in-the-loop performance is not described. The Site-Rite Vision™ is an ultrasound imaging system, not an autonomous algorithm.
7. The Type of Ground Truth Used
For a 510(k) clearance based on substantial equivalence, the "ground truth" is inherently tied to the established safety and effectiveness of the predicate devices that have already been cleared by the FDA for similar indications. The application argues that the new device performs comparably to these already-approved devices, therefore, its "ground truth" is implied by the FDA's previous clearances for the predicates. No new "ground truth" (e.g., pathology, outcomes data) was specifically generated for this submission in a new clinical study.
8. The Sample Size for the Training Set
As this is a traditional ultrasound system and not an AI/ML-driven device requiring a training set, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device, so establishing its ground truth is not applicable.
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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters. The sequence starts with a capital letter 'K', followed by the number '1', and then two 'O's. After that, the numbers '4', '0', and '2' are written. The characters are written in black ink on a white background.
Image /page/0/Picture/1 description: The image shows the logo for "BARD Bard Access Systems". The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "Bard Access Systems" in a smaller, sans-serif font. The logo is black and white.
Site~Rite Vision™ Ultrasound System 510(k) Summary of Safety and Effectiveness
| Device trade name: | Site-Rite Vision™ Ultrasound System | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device class and panel: | Class II, Radiology Devices Panel | |||||||||||||||
| Classification Names: | Name Product Code CFR Number Ultrasonic Pulsed Doppler Imaging System IYN 892.1550 Ultrasonic Pulsed Echo Imaging System IYO 892.1560 Diagnostic Ultrasonic Transducers ITX 892.1570 Picture Archiving and Communications System LLZ 892.2050 | |||||||||||||||
| Applicant name: | Kimberly Geisler, Henry BolandBard Access Systems, Inc. (wholly owned subsidiary of C.R. Bard, Inc.)605 North 5600 West, Salt Lake City, UT 84116(801) 522-5000, x5421 or x5428 | |||||||||||||||
| Predicate devices: | K071204 - Site-Rite® 6 Ultrasound SystemK071134 - SonoSite, Inc. Maxx™ Series Ultrasound SystemK053069, K043559 - SonoSite, Inc. High-Resolution Ultrasound System (C3 Series)K043452, K033367, K030949 - SonoSite, Inc. High-Resolution Ultrasound System (C2 Series) | |||||||||||||||
| Performance Standards: | Performance standards have not been established by the FDA under §514 of theFederal Food, Drug and Cosmetic Act. | |||||||||||||||
| Indications for Use: | The Site-Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imagingor fluid flow analysis of the human body. Specific clinical applications include:Fetal Abdominal Intraoperative (semi-critical†) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric) Typical examinations performed using the Site-Rite Vision™ Ultrasound System include: | |||||||||||||||
| Imaging Applications Exam Type (adult & pediatric) Vascular Assessment of carotid arteries, aorta, deep veins, superficial veinsin the arms and legs, select small vessels supporting organs Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterialline placement, and peripheral vein and artery access Abdominal Assessment of liver, kidneys, pancreas, spleen, gallbladder, bileducts, transplanted organs, abdominal vessels, appendix, andsurrounding anatomical structures Interventional andIntraoperative Guidance for biopsy, drainage, peripheral nerve blocks, andintraoperative procedures (semi-critical†) Superficial Assessment of breast, thyroid, testicle, lymph nodes, hernias,musculo-skeletal procedures, soft tissue structures, and |
1 Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
surrounding anatomical structures
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 9 2010
Bard Access Systems, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K100402
Trade/Device Name: Site-Rite Vision™ Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: February 12, 2010 Received: February 16, 2010
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of March 5, 2010.
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 Site-Rite Vision™ Ultrasound System, as described in your premarket notification:
Transducer Model Number
128 Element Linear Probe with Buttons 128 Element Linear Probe without Buttons 128 Element Convex Probe
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours.
Robert Frecker (for)
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Bard Accesss Systems, Inc.
Site~Rite Vision" Ultrasound System
Traditional 510(k) Premarket Notification
510(k) Number (if known):
Device Name:
Site~Rite Vision™ Ultrasound System
Indications for Use:
The Site Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include:
- Fetal .
- Abdominal .
- Intraoperative (semi-critical1) .
- . Pediatric
- Peripheral Vessel .
- Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) .
- Musculo-skeletal (conventional and superficial) .
- Cardiac (adult and pediatric) .
Typical examinations performed using the Site~Rite Vision™ Ultrasound System include:
| Imaging Applications | Exam Type (adult & pediatric) |
|---|---|
| Vascular | Assessment of carotid arteries, aorta, deep veins, superficial veins in the armsand legs, select small vessels supporting organs |
| Vascular Access | Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterial lineplacement, and peripheral vein and artery access |
| Abdominal | Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts,transplanted organs, abdominal vessels, appendix, and surrounding anatomicalstructures |
| Interventional andIntraoperative | Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperativeprocedures (semi-critical1) |
| Superficial | Assessment of breast, thyroid, testicle, lymph nodes, hemias, musculoskeletalprocedures, soft tissue structures, and surrounding anatomical structures |
T Semi-citical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
Prescription Use V (Part 21 CFR §801 Subpart D)
510K
AND/OR
Over-The-Counter Use (21 CFR §801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)-
Toby H Becker
Division Sign not Parlingia Office of In ion and Safety
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| Clinical Application | Mode of Operation | Other*(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(Specify) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | B+CD | ||||||
| Abdominal | N | B+CD | ||||||
| Intra-operative (semi-critical¹) | N | B+CD | ||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | B+CD | ||||||
| Small Organ (breast, thyroid,parathyroid, testicles, prostate,uterus, ovary) | N | B+CD | ||||||
| Fetal Imaging &Other | Neonatal Cephalic | |||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-Esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | B+CD | ||||||
| Musculo-skeletal (Superficial) | N | B+CD | ||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | N | B+CD | ||||||
| Cardiac Pediatric | N | B+CD | ||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral Vessel | N | B+CD | |||||
| Other (Specify) |
Table 1.3-1 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System
N = new indication; P = previously cleared by FDA; E = added under this appendix
1 Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
Robert Zeckel
(Division Signer - Printed)
(Division Sign-Off) Division of Radiological De Office of In Vitro Dit on and Safety
510K. 5100402
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| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(Specify) | Other(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | B+CD | ||||||
| Abdominal | N | B+CD | ||||||
| Intra-operative (semi-critical1) | N | B+CD | ||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | B+CD | ||||||
| Small Organ (breast, thyroid,parathyroid, testicles, prostate,uterus, ovary) | N | B+CD | ||||||
| Fetal Imaging &Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-Esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | B+CD | ||||||
| Musculo-skeletal (Superficial) | N | B+CD | ||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | N | B+CD | ||||||
| Cardiac Pediatric | N | B+CD | ||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral Vessel | N | B+CD | |||||
| Other (Specify) |
Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System 128 Element Linear Probe with buttons
N = new indication; P = previously cleared by FDA; E = added under this appendix
1 Semi-crilical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
-
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Robert H. Beckerd
(Division Sign-Off)
Division of Radiological Dey Office of In Vitro Diagnostic Device Evaluation and Safety 510H
: ଉତ୍ତରସିଟ
{6}------------------------------------------------
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(Specify) | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | B+CD | |||||||
| Abdominal | N | B+CD | |||||||
| Intra-operative (semi-critical¹) | N | B+CD | |||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | B+CD | |||||||
| Small Organ (breast, thyroid,parathyroid, testicles, prostate,uterus, ovary) | N | B+CD | |||||||
| Fetal Imaging & | Neonatal Cephalic | ||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-Esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | B+CD | |||||||
| Musculo-skeletal (Superficial) | N | B+CD | |||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | N | B+CD | |||||||
| Cardiac Pediatric | N | B+CD | |||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral Vessel | N | B+CD | ||||||
| Vessel | Other (Specify) |
Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – Site~Rite Vision™ Ultrasound
1.3-3. Diagnostic 1997 Diagnostic Officasour.Linear Probe without buttons
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
-
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, N.
The satinity off and and Cales Velecib Imaging Examples of other modes of operation of Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Hamonic Imaging, N.
Robert Becker
(Division Sign-Off)
Division of Radiological Device Division of Radiological Device Evaluation and Safety
510K K100402
: ØØØST
{7}------------------------------------------------
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(Specify) | Other*(Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | B+CD | |||||||
| Abdominal | N | B+CD | |||||||
| Intra-operative (semi-critical¹) | N | B+CD | |||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | B+CD | |||||||
| Small Organ (breast, thyroid,parathyroid, testicles, prostate,uterus, ovary) | |||||||||
| Fetal Imaging & | Neonatal Cephalic | ||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-Esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | B+CD | |||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | N | B+CD | |||||||
| Cardiac Pediatric | N | B+CD | |||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral Vessel | N | B+CD | ||||||
| Vessel | Other (Specify) |
Table 1.3-4 Diagnostic Ultrasound Indications for Use Form - Site~Rite Vision™ Ultrasound System 128 Element Convex Probe
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Semi-crilical is defined as clinical applications in which the probe conlacts mucous membranes or non-intact skin.
-
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Prescription Use (Per 21 CFR 801.109)
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Robert B. Bley/
(Division Sign Off)
(Division Sign-Off) Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100402
§ 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.