(11 days)
Not Found
No
The document describes standard ultrasound technology and image processing techniques, but there is no mention of AI or ML.
No.
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, used to acquire and display ultrasound data for diagnosis, measurement, and analysis, and is not performing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" details how the SA8000 provides "information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components like "scanner," "transducers," and "probes." It also describes physical controls and connections for these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The SA8000 scanner is a diagnostic ultrasound system. It uses sound waves to create images of structures inside the human body. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use clearly describes imaging and fluid flow analysis of the human body.
- Device Description: The description details how the system acquires and displays ultrasound data from within the body.
Therefore, the SA8000 ultrasound system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
SA8000 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)
- Intra-Operative (Neurological, Abdominal, Peripheral vascular)
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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-IYN, 90-ITX
Device Description
The SA8000 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 SA8000 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 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Seventeen different models of transducers are available and any three 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 SA8000 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, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal, and Intra-operative. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8800/HDI1500 (K974269).
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), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), 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 SA8000 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 SA8000 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
- CEVIEC 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
- Compliant with the European Medical Device Directive Certificate issued by TUV.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (e.g., thyroid, parathyroid, breast, scrotum, penis), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult, Pediatric), Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial), Intra-Operative (Neurological, Abdominal, Peripheral vascular).
Indicated Patient Age Range
Adult, pediatric, neonatal
Intended User / Care Setting
Competent health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
NOV 1 6 2001
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 - 3000 Facsimile : 714-889-3079
Email : bdepalma@medison.com
Prepared August 22, 2001
-
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Proprietary Name:
SA8000 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 |
1
3) Identification of the predicate or legally marketed device:
Medison America, Inc. believes that SA 8000 ultrasound system is substantially equivalent to the currently marketed SA 9900 ultrasound system (K002185) and SA8800/HDI1500 ultrasound system (K974269)
Device Description: 4)
The SA8000 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 SA8000 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 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Seventeen different models of transducers are available and any three 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 SA8000 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, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal, and Intra-operative. The same clinical uses were cleared for the predicate devices, SA9900 (K002185) and SA8800/HDI1500 (K974269)
2
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), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), 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 SA8000 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 SA8000 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
- CEVIEC 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
- Compliant with the European Medical Device Directive Certificate issued by . TUV.
3
Intended Use: 5)
SA8000 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)
- . Intra-Operative (Neurological, Abdominal, Peripheral vascular)
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.
4
Technological Characteristics: 6)
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:
| ISPTA | (Maximum Range
720 mW/cm2 |
|-------|------------------------------|
| MI | 1.9 |
The limits are the same as predicate Track 3 devices.
5
Image /page/5/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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Medison America, Inc. % Mr. Mark Job Program Manager TÜV Product Service Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K013627
Trade Name: SonoAce SA-8000 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 Product Code: 90 IYO Product Code: 90 ITX Dated: November 1, 2001 Received: November 5, 2001
Dear Mr. Job:
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 SonoAce SA-8000 Diagnostic Ultrasound System , as described in your premarket notification:
6
Transducer Model Number
Image /page/6/Figure/2 description: The image shows a list of ultrasound transducers with their specifications. The list includes linear arrays such as L5-9EC, L5-9ER, HL5-9ED, L5-10ED, and LI5-9EV, along with curved arrays like C3-7ED, EC4-9ES, and CL4-8EV. Phased arrays such as P2-4AM, P2-5AC, and P3-7AM are also listed, as well as static CW transducers and volume curved arrays like S-VAW3-5, S-VAW4-7, S-VDW5-8(B), and S-VNA5-8(B).
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This 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:
7
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, 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)
8
NOV 1 6 2001
Section 4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No .: System:
Intended Use:
SA8000 Ultrasound System 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 | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7, 8 | |||
| Abdominal | P | P | P | P1 | P | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (See Note 6) | P1 | P1 | P1 | P1 | Note 1 | Notes 8 | |||
| Intra-operative (Neuro.) | P1 | P1 | P1 | P1 | P1 | Note 1 | Notes 8 | ||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Notes 2, 8 | |||
| Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7, 8 | ||
| Adult Cephalic | P | P | P | P | P | Note 1 | Notes 8 | ||
| Trans-rectal | P | P | P | P | Note 1 | Notes 2, 8 | |||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 2, 8 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Notes 2, 8 | |||
| Musculo-skel. (Superfic.) | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 8 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7, 8 | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7, 8 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | N | P | Note 1 | Note 8 | |
| Other (spec.) | N | Note 5 |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 24 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013627
Section 4.3, Page 1
9
| 510(k) No.: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||||
| Transducer: | L5-9EC / 5-9MHz / 7.5 MHz / 40mm 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 | Color | |||||
| Doppler* | 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 | Note 1 | Note 2, 8 | ||||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 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 2, 8 | ||||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 8 | ||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 8 | |||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- Note 2: Includes imaging for guidance of biopsy (P1, P2)
- Note 3: Includes infertility monitoring of follicle development (P1, P2)
and Radiologi 510kl N
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal
10
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | L5-9ER / 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal, | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 8 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 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 2, 8 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 8 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 8 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; Pl= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
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 | |
| 510(k) Number | K013627 |
Section 4.3, Page 3
11
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | HL5-9ED / 5-9MHz / 7.5 MHz / 40mm Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| General | ||||||||
| (Track I only) | Clinical Application | |||||||
| Specific | ||||||||
| (Tracks I & III) | Mode of Operation (*includes simultaneous B-mode) | Combined* | ||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| B | M | PWD | CWD | Color Doppler* | ||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal, vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 8 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 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 2, 8 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 8 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 8 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
| Nancy C. Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | Section 4.3, Page 4 |
| 510(k) Number | K013627 |
12
510(k) No.: SA8000 Ultrasound System System: L5-10ED / 5-10 / 7.5 MHz / 40mm 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 Specific B M PWD CWD Color Combined Other General (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (Abdominal, vascular) Intra-operative (Neuro.) Laparoscopic Fetal Imaging & Other Pediatric N N N Note 1 Note 2, 8 N Small Organ (See Note 5) N N N N Note 1 Note 2, 8 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) N N N N Note l Note 2, 8 Musculo-skel. (Superfic.) Note 1 Note 2, 8 N N N N Intra-luminal Other (spec.) Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel N N N N Note 1 Note 8 Vessel Other (spec.)
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E=added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
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 | |
| 510(k) Number | K013627 |
Section 4.3, Page 5
13
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | LI5-9EV / 5-9MHz / 7.5 MHz / 40mm 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal, vascular) | N | N | N | N | Note 1 | Notes 8 | ||
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Notes 8 | |
| 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 | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 80
Nancy C. Hogdon
Basic Information
14
| 510(k) No.:
System:
Transducer:
Intended Use: | SA8000 Ultrasound System
C3-7ED / 3-7MHz / 4.5 MHz / 50R Curved Array
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 | Color
Doppler | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E=added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 80
Mancy C. bhogdm
(Division Sign-Off
Section 4.3, Page 7
Division of Reproductive, Abdominal,
and Radiological Devices
KO
15
| 510(k) No.: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | ||||||||
| Transducer: | EC4-9ES / 4-9MHz / 6.5 MHz / 10R Curved 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 | Color | ||||
| Doppler* | 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 | N | N | N | N | Note 1 | Note 2, 8 | |||
| Trans-vaginal | N | N | N | N | Note 1 | Note 2, 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.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
U
K01362
Section 4.3, Page 8
16
| 510(k) No.: | |
|---|---|
| System: | SA8000 Ultrasound System |
| Transducer: | CL4-8EV / 4-8MHz / 6.5 MHz / 40R Curved 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 | Color | |||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal ( See Note 3 ) | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Abdominal, vascular) | N | N | N | N | Note 1 | Notes 8 | ||||
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Notes 8 | |||
| 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 | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
Section 4.3, Page 9
Division of Reproductive, Abdominal, and Radiological
17
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | P2-4AM / 2-4 MHz / 2.5 MHz Phased 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 | N | N | N | N | N | Note 1 | Note 7 | |
| Intra-operative | ||||||||
| (Abdominal, | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | |||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Notes 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 | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cription Use (Per 21 CFR 801.109)
Nancy C. Borden
18
510(k) No.: System: SA8000 Ultrasound System Transducer: P2-5AC / 2-5 MHz / 3.5 MHz Phased 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 PWD M CWD Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal N N N N N Note l Note 7 Intra-operative (Abdominal, vascular) 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 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 N N N N N Note l Note 4. 7 Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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) (PI, P2)
- Note 8: 3D Imaging (P1, P2, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hodgson
Sian-olancy nogam
Dancy C. Progdom
Division Sign-Off
Division of Reproductiva/ Abdominal,
nd Radiological Devices un
S
Basic Information
19
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | P3-7AM / 3-7MHz / 5.0 MHz Phased 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | N | N | N | N | N | Note 1 | Note 7 | |
| Intra-operative | ||||||||
| (Abdominal, | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | Note 1 | Note 7 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 7 | |
| 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 | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
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 K0136-
510(k) Number
Nancy C. Brogdon
Basic Information
20
| 510(k) No.: | SA8000 Ultrasound System |
|---|---|
| System: | SA8000 Ultrasound System |
| Transducer: | 2.0CW / 2MHz / Static CW |
| 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 | Color Doppler* | 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.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | |||||||
| Other (spec.) | N | Note 5 |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2=previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E=added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- Note 2: Includes imaging for guidance of biopsy (P1, P2)
- Note 3: Includes infertility monitoring of follicle development (P1, P2)
510k)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal
Basic Information
21
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | 4.0CW / 4MHz / Static CW | |||||||
| 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 | Color | |||
| Doppler* | 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 Adult | N | |||||||
| Cardiac | Cardiac Pediatric | N | ||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | ||||||
| Other (spec.) | N | Note 5 |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
Note 2: Includes imaging for guidance of biopsy (P1, P2)
Note 3: Includes infertility monitoring of follicle development (P1, P2)
510
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Hilary C. hogdon
Basic Information
lite, Abdominal,
Section 4.
22
| 510(k) No.: | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | ||||||||
| Transducer: | S-VAW3-5 / 3-5MHz / 3.5 MHz Volume Curved 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 | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 7, 8 | |||
| Abdominal | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 7, 8 | |||
| Intra-operative (Abdominal, vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P2 | P2 | P2 | P2 | Note 1 | Notes 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.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; Pl= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. hogdon
Basic Information
23
| 510(k) No.: | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | SA8000 Ultrasound System | |||||||
| Transducer: | S-VAW4-7 / 4-7MHz / 4.5 MHz Volume Curved 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) | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 7, 8 | ||
| Abdominal | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative | ||||||||
| (Abdominal, | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 7, 8 | |
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Notes 2, 7, 8 | ||
| 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 K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, scroturn 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Nancy C. broden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013627
Secti
Basic Information
24
| 510(k) No.: | |
|---|---|
| System: | SA8000 Ultrasound System |
| Transducer: | S-VDW5-8(B) / 5-8MHz / 6.5 MHz Volume Curved 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 | Color Doppler* | 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 | P2 | P2 | P2 | P2 | Note 1 | Notes 2, 8 | ||
| Trans-vaginal | P2 | P2 | P2 | P2 | Note 1 | Notes 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
- Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
- 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, P3)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Krogdon
Basic Information
25
| 510(k) No.: | |
|---|---|
| System: | SA8000 Ultrasound System |
| Transducer: | S-VNA5-8(B) / 5-8MHz / 6.5 MHz Volume Curved 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 | Color Doppler* | Combined* | |||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal ( See Note 3 ) | |||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal, vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging & Other | Laparoscopic | ||||||||
| Pediatric | P3 | P3 | P3 | P3 | Note 1 | Note 8 | |||
| Small Organ ( See Note 5 ) | |||||||||
| Neonatal Cephalic | P3 | P3 | P3 | P3 | Note 1 | Note 8 | |||
| 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.) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185 and K974269; P1= previously cleared by FDA in K974269; P2= previously cleared by FDA in K002185; P3= previously cleared by FDA in K984639; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler (P1, P2, P3)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler (P1, P2, P3)
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, P3)
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
510(k) Number K013627 Section 4.3, Page 18
Nancy C. hoodm