(15 days)
Terason 2000, K992505
No
The device description focuses on conventional ultrasound technology, hardware components, and standard image processing and measurement functions. There is no mention of AI, ML, or related terms.
No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, and its intended use is for imaging guidance, not for treatment.
Yes
The "Intended Use / Indications for Use" directly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." The device description further elaborates on its use for various clinical applications and measurements to aid in diagnosis.
No
The device description explicitly states it is a "self contained portable, multiple-mode, and multiple-application ultrasound imaging system" that "contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface". These are hardware components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is an ultrasound imaging system. It uses sound waves to create images of internal structures of the human body.
- Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This involves directly scanning the body, not analyzing samples taken from the body.
- Device Description: The description details the components and functions related to generating and receiving ultrasound signals and processing them into images. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body for:
- Fetal OB/GYN
- Abdominal
- Small Organs (breast, thyroid, testicle)
- Pediatric
- Neonatal Cephalic
- Trans-Vaginal
- Trans-Rectal
- Peripheral Vascular
- Cardiac
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Neonatal head studies.
- Podiatry scans of superficial structures including muscles, tendons and bones.
- General cardiac studies in adults.
- Prostate, bladder and rectum visualization.
Also includes imaging for guidance of biopsy.
Product codes (comma separated list FDA assigned to the subject device)
90-IYO, 90-ITX
Device Description
The Interson USB Ultrasound Probe System is a self contained portable, multiple-mode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection eight transducers to be offered with the system permits a wide range of clinical applications including fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, ophthalmology. With these general areas of intended use, the various transducers adapt the system for the specific imaging tasks.
Eight different models of the USB Ultrasound Probe System are available and any two may be connected at the same time to a USB 2.0 port. In addition to the initial operational settings for each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.
More detailed explanations of these functions and controls are included in the Operator Manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials have been used in accordance to their intended use and are described below for each individual transducer. All of the transducers were previously cleared for use on other Systems..
The Interson USB Ultrasound Probe System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz. These probes can be applied to a variety of fields such as fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, ophthalmology, and urology. The Interson USB Ultrasound Probe System provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipital-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), and LMP (last menstrual period). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of Interson USB Ultrasound Probe System is B-Mode, The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Teratech, Terason 2000, K992505.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac, Shoulders, Abdominal wall, Pelvic, Retroperitoneal cavity, Organs, Superficial structures, Bony structures, Head, Muscles, Tendons, Bones, Prostate, Bladder, Rectum, Eye (Ophthalmic)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Terason 2000, K992505
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Premarket Notification
INTERSON USB Ultrasound
APR 1 7 2007
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: Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116 Gary J. Allsebrook Regulatory Affairs Consultant Telephone: (510) 388-5001 Fax: (510) 276-2648 Email regman10@comcast.net Prepared February 17, 2007
- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
INTERSON USB Ultrasound Probe System
Classification Names:
CFR Number Product Code Ultrasound Puised Echo Imaging System 892.1560 90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX
510(k) Summary of Safety and Effectiveness
Page 1 of 4
1
ldentification of the predicate or legally marketed device: 3)
Interson Corporation believes that INTERSON USB Ultrasound Probe System is substantially equivalent to the currently marketed Terason 2000.
4) Device Description:
The Interson USB Ultrasound Probe System is a self contained portable, multiple-mode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection eight transducers to be offered with the system permits a wide range of clinical applications including fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, ophthalmology. With these general areas of intended use, the various transducers adapt the system for the specific imaging tasks.
Eight different models of the USB Ultrasound Probe System are available and any two may be connected at the same time to a USB 2.0 port. In addition to the initial operational settings for each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.
More detailed explanations of these functions and controls are included in the Operator Manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials have been used in accordance to their intended use and are described below for each individual transducer. All of the transducers were previously cleared for use on other Systems..
510(k) Summary of Safety and Effectiveness
2
510(k) Premarket Notification
The Interson USB Ultrasound Probe System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz. These probes can be applied to a variety of fields such as fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, ophthalmology, and urology. The Interson USB Ultrasound Probe System provides various measuring functions. It can 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), and LMP (last menstral period). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of Interson USB Ultrasound Probe System is B-Mode, The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Teratech, Terason 2000, K992505
2) Intended Use:
- Fetal OB/GYN .
- . Abdominal
- Small Organs (breast, thyroid, testicle) .
- Pediatric .
- Neonatal Cephalic ●
- . Trans-Vaginal
- Trans-Rectal .
- Peripheral Vascular .
- Cardiac .
510(k) Summary of Safety and Effectiveness
3
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, . assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, . shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures. .
- Monitoring procedures for infertility studies (other than in vitro . fertilization).
- First, second and third trimester pregnancy studies. .
- Neonatal head studies, .
- Podiatry scans of superficial structures including muscles, tendons . and bones.
- General cardiac studies in adults. �
- Prostate, bladder and rectum visualization. .
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 images. Scanhead patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications:
| ISPTA.3 | 94 mW/cm2 | (Maximum) |
|---|---|---|
| MI | 1.9 | (Maximum) |
The limits are the same as predicate Track 1 devices.
510(k) Summary of Safety and Effectiveness
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Interson Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
APR 1 7 2007
Re: K070907
Trade Name: INTERSON USB Ultrasound Probe System Regulation Number: 21 CFR §892.1560 Regulation Name: Utrasonic pulsed echo imaging system Regulatory Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: IYO and ITX Dated: March 31, 2007 Received: April 2, 2007
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 INTERSON USB Ultrasound Probe System, as described in your premarket notification:
5
Page 2 - Mr. Mark Job
Transducer Model Number
OP 12.0 MHz MV 12 MHz GP 2.5 MHz VC 7.5 MHz EC 7.5 MHz SF 7.5 MHz SP 7.5 MHz GP 5.0 MHz GP 3.5 MHz
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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
6
Page 3 – Mr. Mark Job
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D., at (240) 276-3666.
Sincerely yours,
David Wm. Lipton
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
7
SECTION 4.3
INDICATIONS FOR USE
Ultrasound Device Indications For Use
510(k) Number: Device Name:
INTERSON USB Ultrasound Probe System
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | N | N | | | | | | | | |
| Fetal | | N | | | | | | | | Note 3 |
| Abdominal | | N | | | | | | | | Note 1
Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| (See note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 3 |
| Small Organ | | N | | | | | | | | Note 3
Note 2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | N | | | | | | | | Note 3 |
| Trans-Vaginal | | N | | | | | | | | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | | | | | | | | |
| Muscular-Skeletal
Superficial | | N | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
-new indication
Note 1: Abdominal, Solid organs, aneurysms,
Note 2: Small Organ: breast, thyroid, testes.
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seppon
(Division Sign-Off) 4
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070907
Indications for Use
Section 4.3, Page 1 of 1
8
K070907
510(k) Number: Device Name: Transducer:
INTERSON USB Ultrasound Probe System GP 2.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | | | | | | | | |
| Abdominal | | N | | | | | | | | Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | | | | | | | | |
| Muscular-Skeletal
Superficial | | N | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Mode of Operation
N=new indication
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
Description File
David h. Sypon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 07090
Indications for Use
Section 4.3, Page 2 of 2
9
510(k) Number: Device Name: Transducer:
INTERSON USB Ultrasound Probe System GP 3.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Mode of Operation
Small Organ: breast, thyroid, testes
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _/
(Division Sign-Off) _/
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Indications for Use
Section 4.3, Page 3 of 3
10
14070807
510(k) Number: Device Name: Transducer:
INTERSON USB Ultrasound Probe System GP 5.0 MHz Mechanical Sector Probe
Indications for Use:
Dlagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2 |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Mode of Operation
reviously Cleared, K951976 Note 2: Small Organ: breast, thyroid, testes.
Concurrence of CDRH, Office of Device Evaluation (ODE)
escription Use
\n
Indications for Use
Section 4.3, Page 4 of 4
11
510(k) Number: Device Name: Transducer:
sducer:
INTERSON USB Ultrasound Probe System SP 7.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skelatal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Mode of Operation
P=Previously Cleared, K951976
Note 3: Includes imaging for guidance of biopsy
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
escription use
(Division Sign-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number
Indications for Use
Section 4.3, Page 5 of 5
12
K070 907
510(k) Number: Device Name: Transducer:
INTERSON USB Ultrasound Probe System SF 7.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2
Note 3 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardlac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | | | | | | | | Note 3 |
| Trans-Vaginal | | P | | | | | | | | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
=Previously Cleared, K951976
Note 2: Small Organ: breast, thyroid, testes
Note 2: Small Organ: breast, thyroid, testes.
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
A Decision Tree
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number
Indications for Use
Section 4.3, Page 6 of 6
13
510(k) Number: Device Name: Transducer:
K 070907 INTERSON USB Ultrasound Probe System
MV 12 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | N | | | | | | | | Note 2
Note 3 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | | | | | | | | Note 3 |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
l=new indication: Note 2: Small Organ: breast, thyrold, testes.
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Gabriel A. Sasso
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 07090
Indications for Use
Section 4.3, Page 7 of 7
14
K 070907
510(k) Number: Device Name: Transducer:
INTERSON USB Ultrasound Probe System EC 7.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | | | | | | | | Note 3 |
| Trans-Vaginal | | P | | | | | | | | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
Previously Cleared, K951976 Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Plan
Oavid by. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Indications for Use
Section 4.3, Page 8 of 8
15
510{k) Number: Device Name: Transducer:
K070907 INTERSON USB Ultrasound Probe System OP 12.0MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as foilows:
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | N | N | N | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletai
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
N=new indication
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tarik Seppam
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Indications for Use
Section 4.3, Page 9 of 9
16
510(k) Number: Device Name: Transducer:
K 070907 INTERSON USB Ultrasound Probe System VC 7.5 MHz Mechanical Sector Probe
Indications for Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 3 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | Note 3 |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |
P=Previously Cleared, K951976
Note 3: Includes imaging for guidance of biopsy
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription O.K.
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070907
Indications for Use
Section 4.3, Page 10 of 10