(6 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
- Fetal (includes infertility monitoring of follicle development)
- Abdominal
- Pediatric
- Small Organ
- Neonatal Cephalic
- Adult Cephalic
- Cardiac (Adult, Pediatric)
- Trans-Rectal
- Trans-Vaginal
- Peripheral-Vascular
- Muscular-Skeletal (conventional, superficial)
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs and bony structures.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal head studies.
- Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Biopsy guidance for tissue or fluid sampling.
- Conventional podiatry scans.
The SA8000 SE system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 SE also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA8000 SE has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Ten different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The SA8000 SE uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using various anatomical measurements and analysis packages. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA8000 SE supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
This document is a 510(k) Premarket Notification for the SA8000 SE Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood for performance metrics like sensitivity or specificity.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices by:
- Device Description: Outlining the SA8000 SE's functions, modes, compatible transducers, and measurement capabilities.
- Intended Use: Listing the clinical applications for which the device is intended (e.g., fetal, abdominal, cardiac imaging). The tables on pages 7-17 detail these indications for the system and each transducer, indicating "N" for new indications.
- Technological Characteristics: Stating that the device operates identically to predicate devices and meets acoustic output limits comparable to predicate Track 3 devices.
- Safety and Performance Standards: Listing various electromechanical safety standards met by the device (e.g., EN 60601-1, UL 2601-1, CEI/IEC 1157).
- Hazard Analysis: Mentioning that a hazard analysis was performed and the "Level of Concern" was classified as "Moderate."
The FDA's letter (pages 4-6) confirms their review of the premarket notification and determination of substantial equivalence, allowing the device to be marketed. It does not mention specific performance acceptance criteria or a study demonstrating achievement of such criteria. The FDA's request for a "postclearance special report" with "acoustic output measurements based on production line devices" is a safety-related requirement, not a performance study for clinical efficacy or diagnostic accuracy.
Therefore, the requested information, particularly regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy (e.g., sensitivity, specificity), cannot be extracted from this document. This type of regulatory submission typically focuses on demonstrating the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a comparative clinical trial against specific acceptance criteria.
To specifically answer your questions based only on the provided text:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document in the format of performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating that the device meets safety standards and performs functionally similarly to predicate devices. The "reported device performance" is implicitly that it operates with the modes and applications listed and meets the specified acoustic output limits of 720 mW/cm² ISPTA and MI 1.9, which are stated to be "the same as predicate Track 3 devices."
Acceptance Criteria (Stated/Implied) Reported Device Performance Acoustic Output ISPTA 720 mW/cm² (Max Range) Acoustic Output MI 1.9 (Max) Compliance with Safety Standards Meets EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157, EN 60601-1-2, EN 60601-2-37, European MDD Certificate Functional Equivalence Operates identically to predicate devices in modes (B-mode, M-mode, Color-Flow Doppler, PW Doppler, Power Doppler, 3D), application range, and measurement capabilities. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document is a 510(k) submission, which demonstrates substantial equivalence, not a clinical study report with a test set of patient data and performance metrics.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No clinical test set or ground truth establishment based on expert review is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (see point 2).
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a diagnostic ultrasound system, not an AI-powered diagnostic assist device. The submission does not mention AI.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (see point 5).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The document describes functional and safety characteristics, not diagnostic accuracy studies requiring ground truth.
-
The sample size for the training set: Not applicable. No machine learning algorithm or training set is mentioned.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows a handwritten string of characters that appear to be alphanumeric. The string reads 'K043455' and is written in a simple, slightly slanted style. The characters are bold and dark against a white background, making them easily readable.
DEC 2 1 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Prepared August 28, 2004
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
Submitter's Information: 21 CFR 807.92(a)(1) 1)
Mr. Kyung-Am. Shim Regulatory Affairs Manager Medison Co. Ltd. Medison Venture Tower, 997-10 Daechi-dong, Kangnam-gu, Seoul 135-280, Korea 82.2.2194.1381 Telephone: Facsimile: 82.2.2194.1399 Email: kashim(amedison.com
2) Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
SA8000 SE Diagnostic Ultrasound System and Transducers
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYC |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3) Identification of the predicate or legally marketed device:
Medison Co., Ltd. believes that SA8000 SE ultrasound system is substantially equivalent to the currently marketed SA 8000 ultrasound system (K013627) and mycolor202 ultrasound system (K031552)
4) Device Description:
The SA8000 SE system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA8000 SE also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SA8000 SE has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
{1}------------------------------------------------
Ten different models of transducers are available and only one can be connected. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. More detailed explanations of these functions and controls are included in Chapter 2 of the Operator manual, and in the software/firmware documentation included in this 510(k) Notification.
The SA8000 SE uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA8000 (K013627) and mycolor202 (K031552)
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (Biparietal Diameter), HC (Head Circumference), OFD (Occipital Frontal Diameter), FL (Femur Length), AC (Abdominal Circumference), FTA (Fetal Trunk Area), APTD (Anterior Posterior Thoracic Diameter), TTD (Transverse Thoracic Diameter), TAD (Transverse Abdominal Diameter), CRL (Crown Rump Length), GS (Gestational Sac), APD (Anterior-Posterior Abdominal Diameter), AFI (Amniotic Fluid Index), APD (Anterior-Posterior Abdominal Diameter), Cerebellum, CLAV(Clavicle), CM (Cisterna Magna), Ear, FIB (Fibular), Foot, HUM (Humerus), IOD (Inner Ocular Distance), LV (Lateral Ventricle), Mid Cerebral Artery, MP (Middle Phalanx), NF (Nuchal Fold), OOD (Outer Ocular Distance), RAD (Radius Length), TIB (Tibia), ULNA (Ulna Length), Umbilical Artery, YS- Yolk Sac, Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, JCA/CCA ratio, Volume flow).
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-roode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA8000 SE supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the
{2}------------------------------------------------
region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output.
Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The SA8000 SE has been designed to meet the following electromechanical safety standards:
- ( EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical Equipment
- ( UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical ( Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, ( Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- { EN 60601-1-2 (IEC 60601-1-2.) European Norm, Collateral Standard: Electromagnetic Compatibility
- EN 60601-2-37 (IEC 60601-2-37,) European Norm, Collateral Standard: ( Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
- Compliant with the European Medical Device Directive Certificate issued ( by TUV.
5) Intended Use:
SA8000 SE intended uses as defined FDA guidance documents are:
- Fetal (includes infertility monitoring of follicle development) (
- Abdominal
- Pediatric (
- Small Organ {
- Neonatal Cephalic (
- Adult Cephalic (
- Cardiac (Adult, Pediatric) (
- Trans-Rectal (
- Trans-Vaginal
- Peripheral-Vascular (
- Muscular-Skeletal (conventional, superficial)
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, { and retroperitoneal cavity studies.
- Study of small parts including breasts, shoulders, thyroid, and the abdominal ( wall.
- Pediatric scans of organs and bony structures. (
ﺴﻤ
{3}------------------------------------------------
- ( Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro fertilization). {
- First, second and third trimester pregnancy studies. (
- ( Prostate, prostate biopsy guidance, and rectal wall studies.
- ( Neonatal head studies.
- { Trans-cranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children. (
- Biopsy guidance for tissue or fluid sampling. (
- Conventional podiatry scans.
6) Technological Characteristics:
This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D and M-mode, Spectral Doppler, Color Doppler, Power Doppler, or 3D images. Transducer patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications: (Maximum Range)
720 mW/cm2 ISPTA
MI 1.9
The limits are the same as predicate Track 3 devices.
7) Conclusion:
The SA8000 SE™ 510(k) Pre-Market Notification contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
SA8000 SE™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes extending from its wing, representing health, services, and people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Medison Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K043455
Trade Name: SA8000 SE 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 IYN, IYO, and ITX Dated: December 14, 2004 Received: December 15, 2004
Dear Mr. Devine:
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 SA8000 SE Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
C2-5ET / 2-5MHz / 3.5 MHz / 40R Curved Linear Array C3-7ED / 3-7MHz / 5.0MHz / 50R Curved Linear Array
{5}------------------------------------------------
C3-7EP / 3-7MHz / 5.0MHz / 50R Curved Linear Array C4-9ED / 4-9MHz / 6.5MHz / 10R Curved Linear Array EC4-9/10ED / 4-9MHz / 6.5MHz / 10R Endocavity Curved Linear Array HL5-9ED / 5-9MHz / 7.5MHz / 40mm Linear Array L5-9EE / 5-9MHz / 7.5 MHz / 50 mm Linear Array P2-4AH / 2-4MHz / 3.0MHz 19.2mm Phased Array 2.0CW / 2MHz / Static CW 4.0CW / 4MHz / Static CW
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 (OS) 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 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.
{6}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marc gacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{7}------------------------------------------------
4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No.:
System: SA8000 SE Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | ||
| Abdominal | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | N | N | N | N | Note 1 | Note 2, 5,7, 8 | |
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 8 | ||
| Neonatal Cephalic | N | N | N | N | Note 1 | Note 2, 5, 8 | ||
| Adult Cephalic | N | |||||||
| Trans-rectal | N | N | N | N | Note 1 | Note 2, 8 | ||
| Trans-vaginal | N | N | N | N | Note 1 | Note 2, 3, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 8 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 8 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4. 7 | |
| Cardiac | Cardiac Pediatric | N | ||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 8 |
| Vessel | Other (spec.) | N |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
- Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
David A. hyrum
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KOH3455
{8}------------------------------------------------
510(k) No.:
SA8000 SE Ultrasound System System:
C2-5ET / 2-5MHz / 3.5 MHz / 40R Curved Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Abdominal | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Intra-operative (Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I : B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Concurrence of CDRH, Office of Dev Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K043455
{9}------------------------------------------------
510(k) No .:
SA8000 SE Ultrasound System System : C3-7ED / 3-7MHz / 5.0 MHz / 50R Curved Linear Array
Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Mode of Operation (includes simultaneous B-mode) Clinical Application Color Combined Other PWD CWD M B General Specific Doppler* (Spec.) (Spec.) (Tracks I & III) (Track I only) Ophthalmic Ophthalmic N N N Note 2, 6, 7, 8 N Note 1 Fetal (See Note 3) N Note 2, 6, 7, 8 N N N Note 1 Abdominal Intra-operative (Abdominal, vascular) Intra-operative (Neuro.) Laparoscopic Fetal Imaging N N N N Note 2, 6, 7, 8 Note l & Other Pediatric
| & Other | Small Organ (See Note 5) | ||||
|---|---|---|---|---|---|
| Neonatal Cephalic | |||||
| Adult Cephalic | |||||
| Trans-rectal | |||||
| Trans-vaginal | |||||
| Trans-urethral | |||||
| Trans-esoph. (non-Cardiac) | |||||
| Musculo-skel. (Convent.) | |||||
| Musculo-skel. (Superfic.) | |||||
| Intra-luminal | |||||
| Other (spec.) | |||||
| Cardiac | Cardiac Adult | ||||
| Cardiac Pediatric | |||||
| Trans-esophageal (Cardiac) | |||||
| Other (spec.) | |||||
| PeripheralVessel | Peripheral vessel | ||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
- Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Concurrence of CDRH, Office o Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K024/3455
{10}------------------------------------------------
510(k) No .:
SA8000 SE Ultrasound System System:
C3-7EP / 3-7MHz / 5.0 MHz / 50R Curved Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 |
| Abdominal | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Intra-operative (Abdominal, vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
-
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
David R. hegeman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
KD434/53
{11}------------------------------------------------
510(k) No .:
SA8000 SE Ultrasound System System:
C4-9ED / 4-9MHz / 6.5 MHz / 10R Curved Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 6, 7, 8 | |
| Abdominal | ||||||||
| Intra-operative(Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 8 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 8 |
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Device Evaluation (ODE)
David A. Seymann
(Division Sign-Of Division of Reproductive, Abdo and Radiological Devices 510(k) Number
{12}------------------------------------------------
510(k) No .:
| System: | SA8000 SE Ultrasound System |
|---|---|
| Transducer: | EC4-9/10ED / 4-9MHz / 6.5 MHz / 10R Endocavity Curved Linear Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| (Track I only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 8 | |
| Abdominal | ||||||||
| Intra-operative(Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 8 | |
| Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 3, 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Concurrence of CDRH, Office of Device B Prescription Use (Per 21 CFR 801.109)
David A. Hagemann
A
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
{13}------------------------------------------------
510(k) No.:
SA8000 SE Ultrasound System System:
HL5-9ED / 5-9MHz / 7.5 MHz / 40mm Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal ( See Note 3 )Abdominal | ||||||||
| Intra-operative (Abdominal, vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Small Organ ( See Note 5 ) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 8 |
| Vessel | Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scroturn and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
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
10(k) Number
073455
{14}------------------------------------------------
510(k) No.:
| System: | SA8000 SE Ultrasound System |
|---|---|
| Transducer: | L5-9EE/ 5-9MHz/ 7.5 MHz/ 50mm Linear Array |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 8 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 8 |
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Daniel A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
155
{15}------------------------------------------------
510(k) No.:
SA8000 SE Ultrasound System System : P2-4AH / 2-4 MHz / 3.0 MHz / 19.2mm Phased Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | |||||||
| Abdominal | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Intra-operative(Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 |
| Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
- Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
David A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043155
{16}------------------------------------------------
510(k) No .:
SA8000 SE Ultrasound System System:
2.0CW / 2MHz / Static CW Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | ||||||
| Other (spec.) | N |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
David H. Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal/
and Radiological Devices
MOVEINumhor
KOHO
0
{17}------------------------------------------------
510(k) Premarket Notification
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No .:
SA8000 SE Ultrasound System System:
Transducer: 4.0CW / 4MHz / Static CW
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal,vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | N | |||||||
| Cardiac Pediatric | N | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | N | |||||||
| Other (spec.) | N |
N= new indication; P= previously cleared; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M
- Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Daniel A. Lippman
(Division Sign-Off) Division of Reproductive. A and Radiological Devices って(Wk) Number
§ 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.