(281 days)
Not Found
No
The description focuses on standard ultrasound imaging modes, digital beamforming, measurement functions, and image processing techniques common to ultrasound systems, without mentioning AI or ML.
No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, and its function is to "acquire ultrasound data and to display the data" for making a diagnosis. There is no mention of it being used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" states "The SA 8800/HDI 1500 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system." and "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "general purpose, mobile, software controlled, diagnostic ultrasound system" and details various hardware components like transducers, control panels, and digital beamforming technology. It is a complete ultrasound system, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "diagnostic ultrasound system." It acquires ultrasound data and displays it as various imaging modes (B-mode, M-mode, Doppler, etc.). It also provides measurement and analysis tools based on these images.
- Method of Diagnosis: The diagnosis is made by "competent health care professionals" using the information provided by the ultrasound images and measurements, not by analyzing a biological sample from the patient.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.).
The device is a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
- Abdominal
- Obstetrical
- Cerebrovascular
- Peripheral vascular
- Gynecological and fertility
- Small parts
- Intraoperative vascular
- Abdominal surgery
- Musculoskeletal (conventional)
- Transcranial Doppler
- Pediatric general imaging
- Prostate
- Adult cardiology
- Pediatric cardiology
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal 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.
- Transcranial 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.
- Intraoperative application including soft tissue structures.
Product codes
90-IYO, 90-IYN, 90-ITX
Device Description
The SA 8800/HDI 1500 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 8800/HDI 1500 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 8800/HDI 1500 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Eight 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. Patient contact materials are the same as those previously cleared in the predicate device, ATL's HDI 5000 Ultrasound System and Transducers (K961459).
The SA-8800/HDI 1500 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 2.0 MHz to 12.0 MHz. These probes can be applied to a variety of clinical applications such as abdominal, obstetrical, cerebrovascular, peripheral vascular, gynecological and fertility, small parts, intraoperative, vascular, abdominal surgery, conventional musculoskeletal, transcranial Doppler, pediatric general imaging, prostate, adult cardiology, pediatric cardiology. The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459).
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal 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 menstrual period.), Cardiac Analysis and Vascular Analysis.
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of SA-8800/HDI 1500 are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor. The SA8800/HDI 1500 supports the Cine function (capable of storing up to 64 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 imagefiling function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
Mentions image processing
Imaging enhancement processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Obstetrical, Cerebrovascular, Peripheral vascular, Gynecological and fertility, Small parts, Intraoperative vascular, Abdominal surgery, Musculoskeletal (conventional), Transcranial Doppler, Pediatric general imaging, Prostate, Adult cardiology, Pediatric cardiology.
Indicated Patient Age Range
Adult, pediatric and neonatal patients, Children
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SA 8800/HDI 1500 Ultrasound System
AUG 21 1998
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: 1) Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588 Bob Leiker Vice President, Regulatory and Quality Telephone: (510) 463-1830
Prepared June 24, 1998
Name of the device, including the trade or proprietary name if applicable, the common or usual 2) name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories
Proprietary Name:
SonoAce 8800 Diagnostic Ultrasound System and Transducers. Also called HDI® 1500 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 |
3) Identification of the predicate or legally marketed device:
Medison America, Inc believes that SA8800/HDI 1.500 Ultrasound system is substantially equivalent to the currently marketed ATL HDI 5000 System, K961459.
1
Device Description: 4)
The SA 8800/HDI 1500 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, Mmode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The SA 8800/HDI 1500 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 8800/HDI 1500 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Eight 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, usercustomized 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. Patient contact materials are the same as those previously cleared in the predicate device, ATL's HDI 5000 Ultrasound System and Transducers (K961459).
The SA-8800/HDI 1500 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 2.0 MHz to 12.0 MHz. These probes can be applied to a variety of clinical applications such as abdominal, obstetrical, cerebrovascular, peripheral vascular, gynecological and fertility, small parts, intraoperative, vascular, abdominal surgery, conventional musculoskeletal, transcranial Doppler, pediatric general imaging, prostate, adult cardiology, pediatric cardiology. The same clinical uses were cleared for the predicate device, ATL's 5000 (K961459).
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal 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 and Vascular Analysis.
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously
2
cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of SA-8800/HDI 1500 are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor. The SA8800/HDI 1500 supports the Cine function (capable of storing up to 64 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 imagefiling function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The SA 8800/HD! 1500 has been designed to meet the following electromechanical safety standards:
- . EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment .
- C22.2 No. 601.1. Canadian Standards Association. Medical Electrical Equipment .
- CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration . of the acoustic output of medical diagnostic ultrasonic equipment
- . EN 60601-1-2 (IEC 601-1-2.) European Norm, Collateral Standard: Electromagnetic compatibility
- Compliant with the European Medical Device Directive Certificate issued by TUV. .
5) Intended Use:
SonoAce 8800/HDI 1500 intended uses as defined FDA guidance documents are:
- . Abdominal
- . Obstetrical
- . Cerebrovascular
- . Peripheral vascular
- . Gynecological and fertility
- . Small parts
- . Intraoperative vascular
- . Abdominal surgery
- . Musculoskeletal (conventional)
- . Transcranial Doppler
- . Pediatric general imaging
- . Prostate
- . Adult cardiology
- Pediatric cardiology .
3
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal 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. .
- Transcranial 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. .
- Intraoperative application including soft tissue structures. .
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 a 2D and M-mode, Continuous wave Doppler, Spectral Doppler, Color Doppler, Power Doppler, 3D images. Scanhead 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.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Robert Leiker Vice President Regulatory and Quality Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588
Re: K974269 Trade Name: SA8800/HDI 1500 Diagnostic Ultrasound System Regulatory Class: II/892.1550/892.1560 Product Code: 90 IYN/90 IYO Dated: July 7, 1998 Received: July 9, 1998
Dear Mr. Leiker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 misbranion.
This determination of substantial equivalence applies to the following transducers intended for use with the SA8800/HDI 1500 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CS-2, C7-4, C9-5ICT, L7-4, L12-5, P4-2, P7-4, D2 CW
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
5
Page 2 - Robert Leiker
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.
Yin L. Aleyr
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 7,
8 |
| Abdominal | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 7,
8 |
| Intraoperative:
(See Note 6) | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 7,
8 |
| Intraoperative
Neurological | | N | N | N | N | N | N | | Note 1 | Notes 4, 8 |
| Pediatric | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 7,
8 |
| Small Organ
(See Note 5) | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 7,
8 |
| Neonatal Cephalic | | N | N | N | N | N | N | | Note 1 | Notes 4, 8 |
| Adult Cephalic | | N | N | N | N | N | N | | Note 1 | Notes 4, 7, 8 |
| Cardiac | | N | N | N | N | N | N | | Note 1 | Notes 4, 7, 8 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | N | N | N | | Note 1 | Note 2, 7, 8 |
| Transvaginal | | N | N | N | N | N | N | | Note 1 | Note 2, 7, 8 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | N | N | N | N | N | N | | Note 1 | Note 4, 8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | N | N | N | N | | Note 1 | Notes 2, 4, 8 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 2: Includes imaging for guidance of biopsy
- Includes infertility monitoring of follicle development Note 3:
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients.
-
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D Imaging
Concurrence of CDRH/Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)Prescription Use (Per 21 CFR 801.109) (x) Number
A Redological Devices TM国, InnimobdA, avitasa incomo includibed but (JJO-ugis noisivia)
7
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | C5-2/5.0-2.0 MHz/40mm/Convex Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
Mode of Operation (*includes simultaneous B-mode)
| Mode of Operation (*Includes simultaneous B-mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M* | PWD* | CWD* | Color | ||||
| Doppler* | Power | |||||||||
| (Amp) | ||||||||||
| Doppler* | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify)* | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, | |||
| 8 | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2, 4, 7, | |||
| 8 | ||||||||||
| Intraoperative: | ||||||||||
| (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Muscuio-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Tissue Harmonic Imaging (THI) Note 7:
Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) SE (Per 21
David C. Segner
(Division Sign-Off)
Reproductive, Abdominal, El and R:
Basic Information
Prescription Use (Per 21 CFR 801.109)
510(k) Number K974269
8
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | C7-4/7.0-4.0 Mhz/40mm/Convex Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7,
8 |
| Abdominal | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7,
8 |
| Intraoperative:
(Specify) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7,
8 |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler,
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- Note 4: Color M-mode
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE Use (Per 21 CFR 801 109)
Thimit C. Seymore
(Division Sign. Off.)
ﺪ Prescription Use (Per 21 CFR 801.109)
oductive, Abdominal, E
Basic Information
9
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | C9-5ICT/9.0-5.0 MHz/8mm/Convex Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | P | P | P | | P | P | | Note 1 | Notes 2, 7, 8 |
| Abdominal | | | | | | | | | | |
| Intraoperative:
(Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | Note 1 | Notes 2, 7, 8 |
| Transvaginal | | P | P | P | | P | P | | Note 1 | Notes 2, 7, 8 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Uttrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 2: Includes imaging for guidance of biopsy.
Note 3: Includes infertility monitoring of follicle development
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging
Concurrence of CDRH. Office of Device Evaluation (ODE)
David A. Watson
Division Sign-off
4 Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k)
10
510(k) Number: K974269 SonoAce 8800 System/HDI 1500 Ultrasound System Device Name: L7-4/7.0-4.0 MHz/38mm/Linear Array Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|---------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7,
8 |
| Intraoperative: | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7,
8 |
| Small Organ | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7, |
| (See Note 5) | | | | | | | | | | 8 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | P | P | P | | P | P | | Note 1 | Notes 4, 8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 8 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 2: Includes imaging for guidance of biopsy
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients.
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) ાદિલ
Prescription Use
(Per 21 CFR 801.109)
Daniel A. Bergman
(Division Sign-Off)
Reproductive, Abdominal, El
Basic Information
11
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | L12-5/12.0-5.0 MHz/38mm/Linear Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative:
(See Note 6) | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7, 8 |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7, 8 |
| Small Organ
(See Note 5) | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 7, 8 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | P | P | P | | P | P | | Note 1 | Notes 4, 8 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | Note 1 | Notes 2, 4, 8 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Uttrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 2: Includes imaging for guidance of biopsy
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients.
- Note 6: Abdominal organs and peripheral vessel
- Tissue Harmonic Imaging (THI) Note 7:
Note 8: 3D Imaging
Concurrence of CDRH, Office of Evaluation (ODF) I levice
Elvin L. Nygaard
Division Sign Off
Prescription Use (Per 21 CFR 801.109)
oductive, Abdominal
Basic Information
Number K974269
12
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | P4-2/4.0-2.0 MHz/20mm/Phased Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Abdominal | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Intraoperative:
(Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Cardiac | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppler.
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging
Concurrence of CDRH. Office of Device Evaluation (ODE)
Daniel A. Teppern
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, and Radi
Basic Information
13
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | P7-4/7.0-4.0 MHz/8mm/Phased Array |
Diagnostic ultrasound imaging or fluid flow analysis of the human body Indications for Use: as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|------|-------------------|----------------------------|------------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal (See Note 3) | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Abdominal | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Intraoperative:
(Specify) | | | | | | | | | | |
| Intraoperative
Neurological | | P | P | P | P | P | P | | Note 1 | Notes 4, 8 |
| Pediatric | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | Note 1 | Notes 4, 8 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | Note 1 | Notes 4, 7, 8 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Mode of Operation (*includes simultaneous B-mode)
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppier, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppier.
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D Imaging
Concurrence of CDRH, Office of D evice Evaluation (ODE)
David C. Seppman
(Division Sign-Off)
Reproductive, Abdor and
Surgical Devices
510(k) Number K974469
Basic Information
Prescription Use
(Per 21 CFR 801.109)
Section 4.3, Page 8
14
| 510(k) Number: | K974269 |
|---|---|
| Device Name: | SA 8800 System/HDI 1500 Ultrasound System |
| Transducer: | D2 CW/2.0 MHz/Static Probe |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as Indications for Use: follows:
Mode of Operation (*includes simultaneous B-mode)
| Clinical Applications | A | B | M* | PWD* | CWD | Color
Doppler* | Power
(Amp)
Doppler* | Color
Velocity
Imaging | Combined
(Specify)* | Other
(Specify) |
|----------------------------------|---|---|----|------|-----|-------------------|----------------------------|------------------------------|------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative:
(Specify) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication; P = All transducers were previously cleared in K961459, Level 10 HDI™ Ultrasound System, all transducers are new to SA 8800/HDI 1500; E = added under Appendix E
Concurrence of CDRH Device Evaluation (ODE) (Per 21 CFR 801 109) on Use
David C. Dejem
(Division Sign-Off)
Division of Reproductive, and Radiological I
510(k) Number
Basic Information
Prescription Use
(Per 21 CFR 801.109)