(8 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, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, and 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. 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 SA-9900PLUS scanner 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, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS 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 SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. Thirteen different models of transducers are available and any four may be connected at the same time. 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 SA-9900PLUS 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 GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), 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, ICA/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-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS 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.
The provided text is a 510(k) Premarket Notification for the SA-9900PLUS Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices (SA 9900 - K002185 and SA8000 - K013627) rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
For a diagnostic ultrasound system like the SA-9900PLUS, acceptance criteria typically involve demonstrating that the new device performs as intended and is as safe and effective as the predicate device. This is primarily achieved by showing that its technological characteristics and intended uses are the same or very similar to the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the "study" demonstrating criteria fulfillment is primarily a comparison of specifications and intended uses against the predicate devices. The document does not contain information about a traditional clinical study with a test set, ground truth established by experts, sample sizes for training or testing, adjudication methods, or MRMC studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) context) | Reported Device Performance (SA-9900PLUS) |
|---|---|
| Intended Use Equivalence: | The SA-9900PLUS has the same clinical applications as predicate devices SA9900 (K002185) and SA8000 (K013627), including fetal, abdominal, pediatric, small organ, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, and muscular-skeletal. Some transducers introduce new indications (marked 'N' in the tables) but these are still within the general scope of diagnostic ultrasound. |
| Technological Characteristics Equivalence: | Uses digital beamforming technology, supports various transducer types (Linear, Convex, Phased Array, Static probes) from 1.0 MHz to 20.0 MHz, and offers B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler, and Power Doppler modes, or combinations thereof. These are presented as identical to predicate devices. |
| Performance (Imaging Capabilities & Measurement Functions): | Provides high resolution, high penetration performance, and various measurement functions (distances, areas, circumferences, volumes, EDD calculations, cardiac and vascular analysis). Cine function (up to 256 images), real-time zoom, and DICOM 3.0 compatibility are also supported. The functionalities for measurement and imaging modes are consistent with general diagnostic ultrasound systems. |
| Acoustic Output Limits: | Maximum ISPTA: 720 mW/cm², Maximum MI: 1.9. These limits are stated to be "the same as predicate Track 3 devices." |
| Electromechanical Safety Standards Compliance: | Meets EN 60601-1 (IEC 601-1), UL 2601-1, CAN/CSA C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2 (IEC 60601-1-2), and is compliant with the European Medical Device Directive. |
| Biocompatibility of Patient Contact Materials: | "Transducer patient contact materials are biocompatible." |
2. Sample size used for the test set and the data provenance:
- The document does not describe a specific "test set" or a formal clinical study with patient data to evaluate the device's performance against predefined acceptance criteria in the way a new, novel device might.
- The data provenance is implicitly from the specifications and performance of the predicate devices (SA 9900 - K002185 and SA8000 - K013627), which would have been cleared based on their own performance data. The SA-9900PLUS is stated to operate "identical to the predicate devices."
- This is a retrospective comparison against existing device specifications rather than a prospective study on new data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with ground truth established by experts in this 510(k) summary. The submission relies on substantial equivalence to predicate devices.
4. Adjudication method for the test set:
- Not applicable. No test set or expert adjudication is described.
5. 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:
- No MRMC study mentioned. This device predates widespread AI integration in diagnostic ultrasound and is being cleared based on substantial equivalence, not a comparative effectiveness study involving human readers and AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a diagnostic ultrasound system, not an AI algorithm, and therefore a "standalone" performance study in the context of AI is not relevant. The device requires a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No explicit ground truth is mentioned as part of this submission for the SA-9900PLUS itself. The "ground truth" for showing equivalence relies on the established safety and effectiveness of the predicate ultrasound systems.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that undergoes a training phase as described in the context of modern AI devices.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device with a training set.
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SA-9900P
510(k) Premarket Notification
AUG - 6 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 name, address, telephone number, contact person:
Bob DePalma (714) 889-3070 Regulatory Affairs Medison America, Inc. 11075 Knott Ave. Cypress, CA 90630 Telephone : 714 - 889 - 3070 714 -- 889 -- 3079 Facsimile : Email : bdepalma@medison.com
Prepared June 14, 2002
- Name of the device, including the trade or proprietary name if applicable, 2) the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories
Proprietary Name:
SA-9900PLUS Diagnostic Ultrasound System and Transducers.
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
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Identification of the predicate or legally marketed device: 3)
Medison America, Inc. believes that SA-9900PLUS ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8000 ultrasound system (K013627).
4) Device Description:
The SA-9900PLUS scanner 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, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA-9900PLUS 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 SA-9900PLUS has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Thirteen different models of transducers are available and any four may be connected at the same time. 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 SA-9900PLUS 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, organ, adult cephalic, cardiac, trans-rectal, small trans-vaginal. peripheral-vascular, and muscular-skeletal. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8000 ultrasound system (K013627).
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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 GS (Gestational Sac), CRL (Crown-Rump Length), YS (Yolk Sac), BPD (Biparietal Diameter), OFD (Occipital-Frontal Diameter), HC (Head Circumference), APD (Anterior-Posterior), Abdominal Diameter, TAD (Transverse Abdominal Diameter), AC (Abdominal Circumference), FTA (Fetal Trunk Area), FL (Femur Length), TTD (Transverse Trunk/Thorax Diameter), APTD (AnteroPosterior TrunkThorax Diameter), HUM (Humerus Length), ULNA (Ulna Length), TIB (Tibia Length), RAD (Radius Length), FIB (Fibula Length), CLAV (Clavicle Length), LV (Lateral Ventricle), CEREB ( Cerebellum Diameter), OOD (Outer Ocular Distance), IOD (Inner Ocular Distance), CM (Cisterna Magna), NF (Nuchal Fold), FOOT (Foot Length), EAR (Ear Length), MP (Middle Phalenix), AFI (Amniotic Fluid Index), 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, ICA/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-mode uses the scroll display method, which has its images flow from the right to the left on the monitor. The SA-9900PLUS 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.
The SA-9900PLUS 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
- o 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
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ultrasonic equipment
- EN 60601-1-2 (IEC 60601-1-2,) European Norm, Collateral Standard: . Electromagnetic Compatibility.
- Compliant with the European Medical Device Directive Certificate issued by . TUV.
Intended Use: 5)
SA-9900PLUS intended uses as defined FDA guidance documents are:
- Fetal (includes infertility monitoring of follicle development) ●
- Abdominal
- . Pediatric
- Small Organ
- 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. .
- Trans-cranial studies of middle cerebral arteries, internal carotid artery, .
{4}------------------------------------------------
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) | |
|---|---|
| ISPTA | 720 mW/cm2 |
| MI | 1.9 |
The limits are the same as predicate Track 3 devices.
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Image /page/5/Picture/11 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "U.S. Department of Health & Human Services USA". The eagle is depicted with three curved lines representing its wings and body, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2003
Medison America, Inc. % Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K032329
Trade Name: SA 9900 Plus Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 28, 2003 Received: July 29, 2003
Dear Ms. Danielson:
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 SA 9900 Plus Diagnostic Ultrasound Systems, as described in your premarket notification:
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Transducer Model Number
C 3-71M / 3-7 MHz / 5.0 MHz / 50R Broadband Curved Array C2-6IC / 2-6 MHz / 60R Broadhand Curved Array 1.5-121M / 5-12 MHz / 7.5 MHz / 40mm Broadband I.inear Array P2-3AC / 2-3 MHz / 2.5 MHz / Broadband Phased Array P2-5AC / 2-5 MHz / 3.5 MHz / Broadband Phased Array P2-5EC / 2-5 MHz / 3.5 MHz / Broadband Phased Array P3-7AC / 3-7 MHz / 5.0 MHz / Broadband Phased Array EC4-9IS / 4-9MHz / 6.5 MHz / 10R Broadband Curved Array S-VA W3-5 / 3-5 MHz / 3.5 MHz / Broadband Volume Curved Array S-VA W4-7 / 4-7 MHz / 4.5 MHz / Broadband Volume Curved Array S-VNW6-12 / 6-12 MHz / 8.0 MHz / Broadband Volume Linear array S-VDW5-8(B) / 5-8 MHz / 6.5 MHz / Broadband Volume Curved Array 2.0CW / 2MHz / 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
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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 80)), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
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)
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Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No.:
System:
SA-9900PLUS Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Abdominal | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P2 | P2 | P2 | P2 | P2 | Note 1 | Note 2,4,5,6,7,8 | |
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 8 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P1 | P1 | P1 | P1 | P1 | Note 1 | Note 4, 7 | |
| Trans-rectal | P | P | P | N | P | Note 1 | Note 2, 3, 8 | |
| Trans-vaginal | P | P | P | N | P | Note 1 | Note 2, 3, 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 6, 8 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 6, 8 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P1 | P1 | P1 | P1 | P1 | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4,7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 5, 6 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P
Note 8: 3D Imaging (P1, P2)
Nancy C Brogdon
Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 11082329
Indication for Use
Section 4.3, Page 1
{9}------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801 109)
Nancy C hogdon
(Division Sign Off)
(Division Sigh Division of Reprodu and Radiological Device 510(k) Number
{10}------------------------------------------------
510(k) No .:
System: SA-9900PLUS Ultrasound System
C3-7IM / 3-7MHz / 5.0 MHz / 50R Broadband Curved Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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) | N | N | N | N | Note 1 | Note 2, 7, 8 | ||
| Abdominal | N | N | N | N | Note 1 | Note 2, 7, 8 | ||
| Intra-operative (Abdominal, vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrown and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{11}------------------------------------------------
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off) and Radiological Devices 510(k) Number _
{12}------------------------------------------------
510(k) No.:
SA-9900PLUS Ultrasound System System:
C2-61C/ 2-6MHz / 60R Broadband Curved Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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) | N | N | N | N | N | Note 1 | Note 2, 7, 8 | |
| Abdominal | N | N | N | N | N | Note 1 | Note 2, 7, 8 | |
| Intra-operative (Abdominal, vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 2, 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 by FDA in K013627 and K002185; Pl= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (PI, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{13}------------------------------------------------
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
Prescription Use (Per 2) CFR 801 109)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number _
{14}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
LS-12IM / 5-12MHz / 7.5 MHz / 40 mm Broadband Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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, 6 | ||
| Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6 | ||
| 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, 6 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 6 | ||
| 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 5, 6 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (PI, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{15}------------------------------------------------
;
;
Prescription Use (Per 21 CFR 801.109)
. . . . . .. .. .. .. ..
Nancyc hogdon
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _
{16}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
P2-3AC / 2-3 MHz / 2.5 MHz / Broadband Phased Array Transducer:
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 | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Notes 4, 7 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | ||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{17}------------------------------------------------
・・・・・・・
. . . . ___ -.
Prescription Use (Per 21 CFR 801 109)
. .
.. .. ...
Nancy C. Snogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
Indication for Use
Section 4.3, Page 10
{18}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
P2-5AC / 2-5 MHz / 3.5 MHz / Broadband Phased Array Transducer:
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 | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P1 | P1 | P1 | P1 | P1 | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P1 | P1 | P1 | P1 | P1 | Note 1 | Note 4, 7 |
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{19}------------------------------------------------
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Comments of Children
Prescription Use (Per 21 CFR 801 109)
: : : :
に、 ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Nancy hogdon
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abde nal and Radiological Devices 510(k) Number _
.
{20}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
P2-5EC / 2-5MHz / 3.5 MHz / Broadband Phased Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| (Abdominal,Intra-operativevascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
{21}------------------------------------------------
510(k) No.:
SA-9900PLUS Ultrasound System System:
P3-7AC / 3-7MHz / 5.0 MHz /Broadband Phased Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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 | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal, vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P2 | P2 | P2 | P2 | P2 | Note 1 | Note 4, 7 | ||
| 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 | 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 by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, I
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Section 4.3, Page
{22}------------------------------------------------
. .---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
、、、
ﻟ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤ
Prescription Use (Per 21 CFR 801.109)
Narcy C. Hodon
(Division Sign-Off)
Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{23}------------------------------------------------
510(k) No.:
SA-9900PLUS Ultrasound System System:
Transducer: EC4-9IS/ 4-9MHz / 6.5 MHz / 10R Broadband Curved Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | |||||||
| 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 | ||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 3, 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (PI)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reprod
Radiological
k) Numbe
{24}------------------------------------------------
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032329
{25}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
S-VA W3-5/ 3-5 MHz / 3.5 MHz / Broadband Volume Curved Array Transducer:
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) | P | P | P | P | Note 1 | Notes 2, 7, 8 | |||
| Abdominal | P | P | P | P | Note 1 | Notes 2, 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 by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{26}------------------------------------------------
・
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hogdon
Division Sign-Off
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abo
and Radiological Devices 510(k) Number _
{27}------------------------------------------------
510(k) No .:
System: SA-9900PLUS Ultrasound System
S-VAW4-7/ 4-7 MHz / 4.5 MHz / Broadband Volume Curved Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks 1 & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||||
| Abdominal | P | P | P | P | Note 1 | Notes 2, 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.) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
{28}------------------------------------------------
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
、
Prescription Use (Per 21 CFR 801.109)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
、 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices V032329
510(k) Number ________________________________________________________________________________________________________________________________________________________________
{29}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound Svstem
Transducer: S-VNW6-12/ 6-12MHz / 8.0 MHz / Broadband Volume 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 | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative(Abdominal,vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 8 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 8 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 8 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix F. Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Nate 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (PI, P2)
Note 4: Color M-mode (PI)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (PI, P2)
Note 8: 3D Imaging (PI, P2)
Concurrence of CDRH, Office of Device I:valuation (ODE)
{30}------------------------------------------------
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
{31}------------------------------------------------
510(k) No.:
System: SA-9900PLUS Ultrasound System
Transducer: S-VDW5-8(B)/ 5-8MHz/ 6.5 MHz/ Broadband Volume Curved Array
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 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 | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 8 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 8 | |
| 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 by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (PI, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2
Note 8: 3D Imaging (P1, P2)
(Division Signtoff)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K032329
ection 4.3, Page 24
{32}------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
SA-9900PLUS Ultrasound System System:
Transducer: 2.0CW / 2MHz / Static CW
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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 | ||||||||
| 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 | P1 | ||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K013627 and K002185; P1= previously cleared by FDA in K013627; P2= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
Note 4: Color M-mode (P1)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P1, P2)
Note 6: Abdominal organs and peripheral vessel (P1, P2)
Note 7: Tissue Harmonic Imaging (THI) (P1, P2)
Note 8: 3D Imaging (P1, P2)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032329
Section 4.3, Page 25
{33}------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive Ah and Radiological Devices 510(k) 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.