(73 days)
No
The summary does not mention AI, ML, or any related terms, and the description of the device's processing capabilities is general.
No.
The intended use and device description clearly state that it is for "ultrasound imaging, measurement and analysis" and is a "diagnostic ultrasound system," indicating its purpose is diagnosis, not therapy.
Yes
The Device Description explicitly states, "The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems."
No
The device description explicitly states it is a "compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, 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 that this device is a diagnostic ultrasound system. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and analysis of various anatomical sites within the human body, which is consistent with the function of an ultrasound machine.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The current modifications do not change the indications for use. Intended Use: As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. They have an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provide digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
Mentions image processing
digital acquisition, processing and display capability
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal
Indicated Patient Age Range
Pediatric; Neonatal & Adult
Intended User / Care Setting
Qualified physician
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)
The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The modified Vivid i/q and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis.
- Requirements Reviews.
- Design Reviews.
- Testing on unit level (Module verification).
- Integration testing (System verification).
- Final Acceptance Testing (Validation).
- Performance testing (Verification).
- Safety testing (Verification).
Transducer materials and other patient contact materials are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vivid i and Vivid q Diagnostic Ultrasound Systems K092140, Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems K092079
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
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is presented in black and white, with the letters and the border appearing in black against a white background. The design is simple yet recognizable, representing the iconic branding of the General Electric company.
K102388 NOV - 4 2010
ું ﻨﻪ
Section 5 — 510(k) Summary
Vivid i/q
1
GE Healthcare
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected, creating a unique and recognizable design.
510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 18th August 2010 |
|---|---|
| Submitter: | GE Healthcare [GE Medical Systems Ultrasound and Primary Care |
| Diagnostics, LLC] | |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Manager | |
| GE Healthcare, [GE Medical Systems Ultrasound and Primary Care | |
| Diagnostics, LLC] | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| GE Healthcare | |
| Secondary Contact Person: | Jim Turner |
| Regulatory Affairs Manager America's Service | |
| GE Healthcare, [GE Medical Systems Ultrasound and Primary Care | |
| Diagnostics, LLC] | |
| T:(262) 544-3359 | |
| F:(414)908-9225 | |
| Device: | |
| Trade Name: | Vivid i and Vivid q Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid i, Vivid q |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90- |
| IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX | |
| Predicate Device(s): | Vivid i and Vivid q Diagnostic Ultrasound Systems K092140 and |
| Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems K092079, | |
| currently in commercial distribution. | |
| Device Description: | The Vivid-i and Vivid-q are compact and portable diagnostic |
| ultrasound systems with integrated keyboard, fold-up LCD type | |
| display and interchangeable electronic-array transducers. They have | |
| an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm | |
| high in transport configuration and provide digital acquisition, | |
| processing and display capability. The user interface includes a | |
| computer keyboard, an intuitive layout of specialized controls, color |
GUI display and Doppler audio.
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.
The current modifications do not change the indications for use. Intended Use: As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.
3
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Technology: The modified Vivid i/q employs the same fundamental scientific technology as its predicate devices.
Comparison with the predicate device shows the modified Vivid i/q is of a comparable type and substantially equivalent to the current Vivid i/q. It has the same overall characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and operating modes as the predicate device.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The modified Vivid i/q and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final Acceptance Testing (Validation) .
- Performance testing (Verification) �
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the modified Vivid i/q to be as safe, and effective as the predicate device(s). The performance of the modified Vivid i/q is substantially equivalent to the predicate device(s). Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21
CFR 820, and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the Vivid i/q Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
Determination of Substantial Equivalence:
4
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV - 4 2010 Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare (GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC) 9900 Innovation Dr. WAUWATOSA W1 53226
Re: K102388
Trade/Device Name: Vivid i and Vivid q Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 4, 2010 Received: October 5, 2010
Dear Mr. Behn:
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 Vivid i and Vivid q Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 9L-RS |
|---|
| E8C-RS |
| 6Tc-RS |
| 6T-RS |
5
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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.
Sincerely yours,
David G. Brown, Ph.D.
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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NOV - 4 2010
510(k) Number (if known):
Device Name: Vivid i/q
Indications for Use:
The current modifications do not change the indications for use. As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.
| Prescription Use | X | ||
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | |||
| AND/OR | |||
| Over-The-Counter Use | ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________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________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ and the other one. (Part 21 CFR 801 Subpart C) | (Part 21 CFR 801 Subpart C) | |
| (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K102388
7
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Diagnostic Ultrasound Indications for Use Form
Vivid i and Vivid a Diagnostic Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse† | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ (specify)[2] | P | P | P | P | P | P | P | P | P | P | P |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | N | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | P | P | P | P | P | N | P | P | P | N | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes:
- [1] Abdominal includes GYN/Pelvic and Renal.
[2] Small organ includes breast, testes, thyroid.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
[2] Small organ includes breast, testes, etc.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
[t] Coded Pulse includes Coded Octave Imaging (COI), and Coded Phase Inversion (CPI),
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
510K
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)
8
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GE Healthcare
510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010
Diagnostic Ultrasound Indications for Use Form
Vivid i/q with 9L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application
| Anatomy/Region of Interest | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse† | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ[2] | P | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | P | P | P | P | ||
| Other (specify) | |||||||||||
| Exam Type, Means of | |||||||||||
| Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N
E = added under Appendix E
- Notes: [1] Abdominal includes GYN/Pelvic and Renal.
- [2] Small organ includes breast, testes, thyroid.
- [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[T] Coded Pulse is for digitally encoded harmonics.
(Division Sign-Off) (Division of Radiological Devices
510K. K102388
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
9
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Diagnostic Ultrasound Indications for Use Form
Vivid i/a with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
| Anatomy/Region of Interest | Mode of Operation | Other | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse† | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P* | N | P | P | P | P* | ||
| Abdominal[1] | P | P | P | P* | N | P | P | P | P* | ||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P | P | P | P | P* | P | P | P | P* | ||
| Exam Type, Means of | |||||||||||
| Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | P | P | P | P | P* | P | P | P | P* | ||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
= previously cleared by FDA on Vivid i/q (K033139) P = previously cleared by FDA on Vivid S5/S6 (K092079)); E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic and Renal.
[4] Other use includes Urology.
(Division Sign-Off) Division of Radiological Devices
4] Other use includes Urology.
Office of In Vitro Diagnostic Devicess
Office of In Vitro Diagnostic Device Evaluation and ! (*) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
510K
[T] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
10
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510(k) Premarket Notification Submission Vivid i/q Ultrasound System August 18, 2010
Diagnostic Ultrasound Indications for Use Form
Vivid i/a with 6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
| Anatomy/Region of Interest | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | |||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P* | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of | |||||||||||
| Access | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P* | |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication;
P = previously cleared by FDA, P* = previously cleared by FDA on Vivid S5/S6 (K092079))
E = added under Appendix E
Notes:
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[T] Coded Pulse is for digitally encoded harmonics.
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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safe
510K K102388
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
11
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Diagnostic Ultrasound Indications for Use Form ·
Vivid i/q -with 6T-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes * | Harmonic
Imaging | Coded
Pulse | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|---------------------|---------------------|----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P* | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P* | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative (specify) [5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication;
P = previously cleared by FDA, P* = previously cleared by FDA on Vivid S5/S6 (K092079));
E = added under Appendix E
Notes:
[3] Cardiac is Adult and Pediatric.
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Color M.
[T]Coded Pulse is for digitally encoded harmonics.
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
K102388
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)