(126 days)
Not Found
No
The device description and performance studies focus on traditional ultrasound technology, hardware, and electrical safety testing. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, which is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also refers to it as a "diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images".
No
The device description explicitly states it is a "PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system". It also mentions supporting various probes (mechanical sector, electronic linear and curve array) and includes extensive non-clinical testing related to acoustic output, electrical safety, and electromagnetic compatibility, all of which are characteristic of hardware-based medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 that this device is a "Diagnostic ultrasound imaging or fluid flow analysis of the human body". It produces images and analyzes blood flow within the body, not on samples taken from the body.
- Intended Use: The intended use lists various anatomical sites for imaging and analysis in vivo.
- Device Description: The description details a real-time ultrasound system with probes that interact with the body's surface or internal cavities.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of diagnostic imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
For the GPS-6TBMD - ULTRASOUND SYSTEM:
Clinical applications with indicated modes of operations are:
Fetal: B, M (Combined: M + ref B)
Abdominal: B, M, PWD (Combined: M + ref B, PWD + ref B)
Small Organ (Breast, Thyroid, Testes): B, M, PWD (Combined: M + ref B, PWD + ref B)
Cardiac: B, M, PWD (Combined: M + ref B, PWD + ref B)
Transvaginal: B, M (Combined: M + ref B)
Peripheral Vascular: B, M, PWD (Combined: M + ref B, PWD + ref B)
Musculo-skeletal Conventional: B, M, PWD (Combined: M + ref B, PWD + ref B)
For the GP-3.0 MHz Mechanical Sector-Transducer:
Clinical applications with indicated modes of operations are:
Fetal: B, M (Combined: M + ref B)
Abdominal: B, M, PWD (Combined: M + ref B, PWD + ref B)
Small Organ (Breast, Thyroid, Testes): B, M, PWD (Combined: M + ref B, PWD + ref B)
Cardiac: B, M, PWD (Combined: M + ref B, PWD + ref B)
Transvaginal: B, M (Combined: M + ref B)
Peripheral Vascular: B, M, PWD (Combined: M + ref B, PWD + ref B)
Musculo-skeletal Conventional: B, M, PWD (Combined: M + ref B, PWD + ref B)
For the CA-3.5 MHz Curve Array-Transducer:
Clinical applications with indicated modes of operations are:
Fetal: B (Combined: M + ref B)
Abdominal: B, PWD (Combined: PWD + ref B)
Small Organ (Breast, Thyroid, Testes): B, PWD (Combined: PWD + ref B)
Cardiac: B, M, PWD (Combined: M + ref B, PWD + ref B)
Musculo-skeletal Conventional: B, PWD (Combined: PWD + ref B)
For the ER-6.5 MHz Mechanical-Transducer:
Clinical application with indicated mode of operation is:
Transrectal: B
For the EV-6.5 MHz Curve Array-Transducer:
Clinical applications with indicated modes of operations are:
Fetal: B, M (Combined: M + ref B)
Transvaginal: B, M (Combined: M + ref B)
For the LA-7.5 MHz Linear Array-Transducer:
Clinical applications with indicated modes of operations are:
Small Organ (Breast, Thyroid, Testes): B
Peripheral Vascular: A, B, M (Combined: M + ref B, PWD + ref B)
For the PV-12.5 MHz Mechanical Sector-Transducer:
Clinical applications with indicated modes of operations are:
Small Organ (Breast, Thyroid, Testes): B
Peripheral Vascular: A, B, M (Combined: M + ref B)
Product codes
90 IYN
Device Description
The Perception's GPS-6TBMD Ultrasound System is a PC (computer) based and controlled real time. two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation.
The following intended uses are identified for the transducer applications: General Radiology, Urology, Abdominal, Cardiac, Trans-vaginal, Trans-rectal, Vascular, Small Organs, Breast, Thyroid, Fetal Imaging and Musculo-Skeletal (conventional) with the use of ultrasonic probes from 3.0-12.5 MHz. There are no transcranial applications for this device.
User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-6TBMD Diagnostic Ultrasound System supports M. B. M&B, Dual B, Quad B, D and D/B, display modes.
All probes currently intended for use with the Perception GPS-6TBMD Diagnostic Ultrasound System are either mechanical sector devices or electronic linear and curve array, and make use of a fluid filled design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Radiology, Urology, Abdominal, Cardiac, Trans-vaginal, Trans-rectal, Vascular, Small Organs, Breast, Thyroid, Fetal, Musculo-Skeletal (conventional)
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)
Non-Clinical Test: Acoustic Output Reporting was prepared utilizing NEMA 1992 (Acoustic output measurement standard for diagnostic ultrasound equipment, NEMA Standard UD-21992) and FDA Center for Devices and Radiological Health 1985 510(k) Guide for Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices. Testing included Maximum Acoustic Output Information, Estimated In-Situ Intensity, FDA In-Situ Intensity Limits, and Acoustic Output Information for each system/transducer/mode combination.
A contract-testing laboratory conducted testing based on UL-544, Third Edition; Radiated and Conducted Emissions per CISPR 11; Magnetic Field Emissions per MIL-STD-482D, method RE101; Electrostatic Discharge Immunity per IEC 801-2; Radiated Field Immunity (3 V/m, 26 MHz to 1 GHz, 100% Square wave Modulation); Steady State Voltage Fluctuations; Line Voltage Dropouts; Slow Line Voltage Sags and Surges; Fast Transients Bursts per IEC 801-4; Fast Line Voltage Surges; Conducted Energy Immunity per MIL-STD-462D, Method CS114; Magnetic Field Immunity per MIL-STD-482D, Method RS 101; Quasi-Static Electric Field Immunity.
Key Results: None of the testing demonstrated any design characteristics that violated the requirements of the September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, Center for Devices and Radiological Health" or resulted in any safety hazards. The contract testing Laboratory's conclusions were that the device met all relevant requirements of the aforementioned guidance testing requirements.
Clinical Test: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963616, K935024, K924079, K962662, K#972973, K#972192, K#900469, K#961229
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
SEP 2 9 1998
L 981834
EXHIBIT #B
8 Pages
510(k) SUMMARY
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K981 834 .
1. Submitter's Identification :
Perception Inc. 9344 N.W. 13th Street, Suite 200 Miami, Florida 33172 Contact Person : Mr. Jorge Millan
Date Summary Prepared: April 17, 1998
2. Name of the Device :
Perception Inc. GPS-6TBMD Diagnostic Ultrasound System
3. Predicate Device Information :
-
- Aloka Co. SSD-1700 K963616 Model
2. Diasonics Ultrasound
| Models | Synergy
CFM800
EchoPac | K935024
K924079
K962662 |
| -------- | ------------------------------ | ------------------------------- |
|---|
3. Perception Inc.
| Model | GPS-TUV | K#972973. |
|---|---|---|
| Model | GPS-XYZ | K#972192 |
-
- Pie Medical Ultrasound Model Scanner #1150 K#900469
5. International Ultrasound Co. HRI 2000 K#961229 Model
1
4. Device Description :
General Description
The Perception's GPS-6TBMD Ultrasound System is a PC (computer) based and controlled real time. two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation.
The following intended uses are identified for the transducer applications: General Radiology, Urology, Abdominal, Cardiac, Trans-vaginal, Trans-rectal, Vascular, Small Organs, Breast, Thyroid, Fetal Imaging and Musculo-Skeletal (conventional) with the use of ultrasonic probes from 3.0-12.5 MHz. There are no transcranial applications for this device.
User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-6TBMD Diagnostic Ultrasound System supports M. B. M&B, Dual B, Quad B, D and D/B, display modes.
All probes currently intended for use with the Perception GPS-6TBMD Diagnostic Ultrasound System are either mechanical sector devices or electronic linear and curve array, and make use of a fluid filled design. Transducer parameters are summarized in the following table:
| App/Prob/
Freq(MHz) | GP-3.0
2.8 | CA-3.5
3.5 | EV-6.5
6.5 | ER-6.5
6.5 | LA-7.5
6.5 | PV-12.5
12.5 |
|----------------------------------------------------------------|---------------|---------------|---------------|---------------|---------------|-----------------|
| Abdominal | M/B/PWD | B/PWD | | | | |
| Cardiac | M/B/PWD | B/PWD | | | | |
| Vascular | | | | | M/B/PWD | M/B |
| Trans-rect | | | | B | | |
| Trans-vag | | | M/B | | | |
| Small Organ
Breast, Thyroid,
Testes, Musculo-
skeleta | M/B/PWD | B/PWD | | | B | B |
| Fetal | M/B | B | M/B | | | |
2
5. Intended Use:
See Attachment.
6. Comparison to Predicate Devices:
We believe the Perception Inc. GPS-6TBMD Diagnostic Ultrasound System to be substantially equivalent to ultrasound devices currently in commercial distribution in the U.S. A table of comparison outlining similarities and differences between the Perception Inc. GPS-6TBMD Diagnostic Ultrasound System and predicate devices is attached to this summary.
7. Discussion on Non-Clinical Test Performed for Determination of Substantial Equivalence are as Follows:
This 510(k) submission is intended as a Track 1 type submission. Acoustic Output Reporting was prepared utilizing the following documents.
- NEMA 1992, Acoustic output measurement standard for diagnostic . ultrasound equipment, NEMA Standard UD-21992.
- FDA Center for Devices and Radiological Health 1985 510(k) Guide for . Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices, December 1985, Revised, 1989, 1990, 1991,1993, 1994, and 1995.
Acoustic output of each system/transducer/mode/application combination was measured and calculated per the above documents. The following testing was conducted which revealed satisfactory testing results and compliance to applicable standards.
- Maximum Acoustic Output Information .
- Estimated In-Situ Intensity .
- FDA In-Situ Intensity Limits ●
- Acoustic Output Information for each system/transducer/mode . combination
A contract-testing laboratory conducted the following testing:
- UL-544, Third Edition ●
- Radiated and Conducted Emissions per CISPR 11 ●
- Magnetic Field Emissions per MIL-STD-482D, method RE101 .
- Electrostatic Discharge Immunity per IEC 801-2 .
3
- Radiated Field Immunity (3 V/m,26 MHz to 1 Ghz,100% Square wave Modulation)
- Steady State Voltage Fluctuations ●
- Line Voltage Dropouts ●
- Slow Line Voltage Sags and Surges .
- Fast Transients Bursts per IEC 801-4 .
- Fast Line Voltage Surges ●
- Conducted Energy Immunity per MIL-STD-462D, Method CS114 .
- Magnetic Field Immunity per MIL-STD-482D,Method RS 101 .
- Quasi-Static Electric Field Immunity .
None of the testing demonstrated any design characteristics that violated the requirements of the September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, Center for Devices and Radiological Health" or resulted in any safety hazards. It was the contract testing Laboratory's conclusions that the device tested met all relevant requirements of the aforementioned guidance testing requirements.
8. Discussion of Clinical Test Performed:
Not Applicable
9. Conclusions:
The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System has the same intended use as a combination of all cited predicates. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. This, when compared to the predicate devices, the Perception Inc. GPS-6TBMD Diagnostic Ultrasound System does not incorporated any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
SEP 2 9 10
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jorge Millan Official Correspondent Perception, Inc. 9344 N.W. 13th Street Suite 200 Miami, FL 33172
K981834 Re : GPS-6TMD Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Dated: September 10, 1998 September 11, 1998 Received:
Dear Mr. Millan:
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 misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the GPS-6TMD Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
GP-3.0 MHz Mechanical Sector CA-3.5 MHz Curved Array EV-6.5 MHz Curved Array ER-6.5 MHz Mechanical Sector LA-7.5 MHz Linear Array PV-12.5 MHz Mechanical Sector
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.
5
Page 2 - Jorge Millan
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.
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 tollfree 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,
Jind li. Sejim
Lillian Yin, PhD
illian 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
Enclosure
6
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | X | X | M+ref B | |||||||
| Abdominal | X | X | X | M+ref B | ||||||
| PWD + ref B | ||||||||||
| Intraoperative(specify | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | X | X | X | M+ref B | ||||||
| PWD + ref B | ||||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | X | X | M+ref B | ||||||
| PWD + ref B | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | X | |||||||||
| Transvaginal | X | X | M+ref B | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | X | M+ref B | ||||||
| PWD + ref B | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | X | X | X | M+ref B | ||||||
| PWD + ref B | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
GPS-6TBMD - ULTRASOUND SYSTEM
N= new indication; P= previously cleared by FDA; E= Added under Appendix E
Additional Comments: Small Organs: Breast, Thyroid, Testes.
STO(k) Number
Jain Se
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use _ (Per 21 CFR 801.109) سسسسسسسس
7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | X | X | M+ ref B | |||||||
| Abdominal | X | X | X | M+ ref B | ||||||
| PWD + ref B | ||||||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | X | X | X | M+ ref B | ||||||
| PWD + ref B | ||||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | X | X | M+ ref B | ||||||
| PWD + ref B | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | X | X | X | M+ ref B | ||||||
| PWD + ref B | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
GP-3.0 MHz Mechanical Sector-Transducer
N= new indication; P= previously cleared by FDA; E= Added under Appendix E
Additional Comments: Small Organs: Breast, Thyroid, Testes.
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number. K981834
8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | × | |||||||||
| Abdominal | × | × | PWD+ ref B | |||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | × | × | PWD+ ref B | |||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | × | × | × | M+ ref B | ||||||
| PWD+ ref B | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | × | × | PWD+ ref B | |||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
CA-3.5 MHz Curve Array-Transducer
N= new indication; P= previously cleared by FDA; E= Added under Appendix E
Additional Comments: Small Organs: Breast, Thyroid, Testes.
Prescription Use
(Per 21 CFR 801.109) ✓
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981834
9
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined | |||||||||||
| (specify) | Other | |||||||||||
| (specify) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| ntraoperative(specify | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonathal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | X | |||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Other (specify) |
ER-6.5 MHz Mechanical-Transducer
Additional Comments: NONE
Simit U. Segun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Deyi
510(k) Number ـ
ﺴﺎ
10
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | X | X | M+ ref B | |||||||
| Abdominal | ||||||||||
| Intraoperative(specify | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | X | X | M+ ref B | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
EV-6.5 MHz Curve Array-Transducer
Additional Comments: NONE
Prescription Use
(Per 21 CFR 801.109) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981834
11
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | X | |||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | X | M+ ref B | ||||||
| PWD+ ref B | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
LA-7.5 MHz Linear Array-Transducer
N= new indication; P= previously cleared by FDA; E= Added under Appendix E
Additional Comments: Small Organs: Breast, Thyroid, Testes.
and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981834
12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operations | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color Velocity | ||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | X | ||||||||||
| Neonathal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | X | X | X | M + ref B | |||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
PV-12.5 MHz Mechanical Sector-Transducer
N= new indication; P= previously cleared by FDA; E= Added under Appendix E
Additional Comments: Small Organs: Breast, Thyroid, Testes.
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices.
510(k) Number. K981834