(14 days)
The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or a separate power supply/charger. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist for use in various departments and patient care areas (e.g., OR, ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations.
The provided 510(k) Premarket Notification Submission for the GE Healthcare LOGIQ i, LOGIQ e, and Vivid e ultrasound systems does not include acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality statistics.
Instead, this submission is centered on demonstrating substantial equivalence to existing predicate devices (LOGIQ i, LOGIQ e, Vivid e, K102256, and LOGIO E9 K110943). The document explicitly states:
- "The subject of this premarket submission, LOGIQ i/e & Vivid e, did not require clinical studies to support substantial equivalence." (Page 2)
- "GE Healthcare considers the LOGIQ i/e & Vivid e to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 2)
The 510(k) summary focuses on non-clinical tests and compliance with voluntary standards to assert equivalence. These include: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation).
Therefore, many of the requested categories related to performance studies, sample sizes, expert ground truth, and comparative effectiveness cannot be extracted from this document as these types of studies were not conducted or reported for this submission.
However, I can extract information regarding the intended use and modes of operation for various transducers, which were likely evaluated for functionality and safety, but not for specific performance metrics in comparison to clinical outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or corresponding device performance results from clinical studies are stated in this 510(k) for the purpose of demonstrating device performance against specific metrics. The "acceptance criteria" for this submission appear to be based on compliance with voluntary standards and verification/validation testing of the system's functionality and safety, asserting substantial equivalence to predicate devices.
The tables within the document (e.g., Pages 7-21) indicate the intended clinical applications and modes of operation for the main system and each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, 16L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D, 6Tc-RS, L8-18i-RS). These tables list whether a particular mode (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) is "P" (previously cleared by FDA) or "N" (new indication) for a given anatomical region/clinical application. This indicates the functional scope of the device for which substantial equivalence is claimed, rather than performance against a quantitative criterion.
Example Table Structure (based on the provided information, but without performance data):
| Acceptance Criteria (Functional) | Reported Device Performance (Declaration of Substantial Equivalence) |
|---|---|
| System Functionality & Safety (Non-Clinical) | |
| Compliance with voluntary standards (Section 9, 11, 17) | System complies with voluntary standards. |
| Risk Analysis conducted | Yes |
| Requirements Reviews | Yes |
| Design Reviews | Yes |
| Unit level testing (Module verification) | Yes |
| Integration testing (System verification) | Yes |
| Performance testing (Verification) | Yes |
| Safety testing (Verification) | Yes |
| Simulated use testing (Validation) | Yes |
| Transducer and patient contact materials biocompatible | Yes |
| Clinical Applications (Supported by Predicate Equivalence) | |
| For LOGIQ i/e & Vivid e (General System): | |
| Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult & pediatric), Peripheral Vascular, Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, Thoracic/Pleural (motion/sliding and fluid detection). | Declared substantially equivalent to predicate devices for these applications and modes of operation. |
| For Specific Transducers (e.g., 4C-RS, 8C-RS, E8C-RS, etc.): | |
| Support for specified modes (B, M, PW Doppler, etc.) for various clinical applications (as detailed in tables on pages 7-21). | "P" (previously cleared) or "N" (new indication asserted as equivalent based on non-clinical testing and comparison to predicates). |
2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set data is reported as clinical studies were not required for this substantial equivalence submission.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth established by experts is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set data is reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI. No MRMC study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an ultrasound imaging system, not an algorithm being evaluated in a standalone performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth data is reported. The foundational ground truth for this submission is the established safety and effectiveness of the identified predicate devices.
8. The sample size for the training set
- Not applicable. This premarket notification does not describe an AI/machine learning model where a training set sample size would be relevant.
9. How the ground truth for the training set was established
- Not applicable. As above, this submission does not describe an AI/machine learning model.
{0}------------------------------------------------
DEC 2 9 2011
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: December 14, 2011 Date: Submitter: GE Healthcare 9900 W. Innovation Dr. Wauwatosa, WI 53226 Primary Contact Person: Brvan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Secondary Contact Person: Yalan Wu Regulatory Affairs Manager GE Healthcare T: +86 510 8527 8652 F: +86 510 8527 7347 Device: Trade Name: LOGIQ i, LOGIQ e, Vivid e Common/Usual Name: LOGIQ i, LOGIQ e, Vivid e Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560. 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): LOGIQ i, LOGIQ e, Vivid e, K102256 LOGIO E9 K110943 Device Description: The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or a separate power supply/charger. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist
for use in various departments and patient care areas (e.g., OR,
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Image /page/1/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design is stylized and recognizable as the brand symbol for the company.
GE Healthcare 510(k) Premarket Notification Submission
ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations. The LOGIO i/e & Vivid e is a general purpose ultrasound Intended Use: system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
The LOGIQ i/e & Vivid e employs the same fundamental Technology: scientific technology as its predicate.
Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The LOGIQ i/e & Vivid e 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)
- · Performance testing (Verification)
- Safety testing (Verification
- · Simulated use testing (Validation)
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
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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 are stylized with curved lines and a vintage design, and the border has a decorative pattern.
GE Healthcare 510(k) Premarket Notification Submission
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ i/e & Vivid e, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ i/e & Vivid e to be as safe, Conclusion: as effective, and performance is substantially equivalent to the predicate device(s).
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The overall design is simple and conveys a sense of professionalism and authority.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Bryan Behn GE Healthcare Regulatory Affairs Manager 9900 W Innovation Drive WAUWATOSA WI 53226
JAN 1 9 2012
Re: K113690
Trade/Device Name: GE LOGIQ I, LOGIQ e and Vivid e Diagnostic Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 14, 2011 Received: December 15, 2011
Dear Mr. Behn:
This letter corrects our substantially equivalent letter of December 29, 2011.
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 GE LOGIQ I, LOGIQ e and Vivid e Diagnostic Ultrasound, as described in your premarket notification:
Transducer Model Number
| 4C-RS | 12L-RS | 6S-RS |
|---|---|---|
| 8C-RS | 16L-RS | P2D |
| E8C-RS | i12L-RS | 6Tc-RS |
| 8L-RS | i/t739-RS | L8-18i-RS |
| 9L-RS | 3S-RS |
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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/CDRH/CDRHOffices/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/ReportaProblem/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 Michael O'Hara at (301) 796-0294.
Sincerely Yours,
Michael D'Antoni for
Mary S. Pastel, Sc.D. 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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Image /page/5/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border is decorated with small dots or circles, giving it a textured appearance. The logo is simple and iconic, representing the well-known multinational conglomerate.
GE Healthcare ー 510(k) Premarket Notification Submission
510(k) Number (if known):
GE LOGIQ I, LOGIQ e and Vivid e Diagnostic Ultrasound Device Name:
Indications for Use:
The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use N/A (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)
Mary S. Patil
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
Page 1 of 1
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and connected, with the "G" looping around the "E". The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
Indications For Use Forms
The following Indication for Use forms are attached.
System: GE LOGIQ ile & Vivid e Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 8L-RS Transducer: 9L-RS Transducer: 12L-RS Transducer: 16L-RS Transducer: i12L-RS Transducer: i/t739-RS Transducer: 3S-RS Transducer: 6S-RS Transducer: P2D Transducer: 6Tc-RS Transducer: L8-18i-RS
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ i/e & Vivid e system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified LOGIO i/e & Vivid e. The subject modification does not alter the previously cleared system level indications or clinical applications.
Mary's Protel
DIVISION SIGH:OH
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113690
Confidential and Privileged. This document continential and privileged under . information of General Electric Co. and as such may not be disclosed to others not employed by General Electic Co. All rights reserved
{7}------------------------------------------------
GE Compact Ultrasound System LOGIO i, LOGIO e, Vivid e
Mode of Operation Power Combined Harmonic Coded Other Color M Clinical Application CW Color PW M B Imaging Pulse Doppler Doppler Modes Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic P P P P P P P P P P Fetal / Obstetrics P P P P Abdomina[1] P P P P P P P P P P P P P P P P Pediatric P P P Small Organ 121 P P P p P P P P P P P P P P P Neonatal Cephalic P P P P P P P P P P Adult Cephalic P P P P P P P P P Cardiaclif P P P P P Peripheral Vascular P P P P P P P P P P P P P Musculo-skeletal Conventional P P P P Musculo-skeletal P P P P Superficial P P P P Thoracic/Pleural(specify)41 P P P P P P P P Other الموار P p P P P P P P Exam Type, Means of Access P P P P P P P P P P Transesophageal Transectal P P P P P P P P P P P P P P Transvaginal Transurethral Intraoperative(specify)(6) P P P P P P P P Intraoperative Neurological Intravascular Laparoscopic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
of fluid and pleural thickening,
includes Urology/Prostate
Office of in Ve
[6] Intraoperative includes abdominal, thoracic and peripheral;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics.
Marr S/Pratt
(Division Sign-Off)
Division of Radiological Devices Offica of In Vitro Diagnostic Device Evaluation and Safety
810K
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{8}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 4C-RS Transducer
Mode of Operation Color M Power Other Combined Coded Clinical Application CW Color Harmonic PW B ખ Pulse Modes Imaging Doppler Doppler Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic P P P P P Fetal / Obstetrics P P P P P P P Abdominal!!! P P P P P P P P P P P P Pediatric Small Organ (2) Neonatal Cephalic Adult Cephalic Cardiad II Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial P P Thoracic/Pleural(specify) (4) P P P P P P Other 151 P P P P P P P P Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethral Intraoperative (specify)[6] Intraoperative Neurological Intravascular Laparoscopic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral; 1*1 Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[""] Combined modes are B/M, B/P WD, B/Color* WD,
Q.S.A.P.L. - Spatially encoded harmonics
[*] Coded Pulse is for digitally encoded harmonics.
Mary Shady
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sefety
610K K113690
(PLEASE DO NOT WRITE BELQW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{9}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes' | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ [2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | |||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | P | P | P | P | P | P | P | |||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | |||
| Thoracic/Pleura(specify) [4] | P | P | P | P | P | P | P | P | |||
| Other[5] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify) [6] | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWF30K
{"} Coded Pulse is for digitally encoded harmonics .
Mary S Patil
(Division Sign-Off)
Division of Redictories De Office of In Vitro
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/ Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | |||
| Abdominal (1) | P | P | P | P | P | P | P | |||
| Pediatric | ||||||||||
| Small Organ [2] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Peripheral Vascular | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Thoracic/Pleura(specify) (4) | ||||||||||
| Other [5] | P | P | P | P | P | P | P | |||
| Exam Type, Means ofAccess | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | |||
| Transvaginal | P | P | P | P | P | P | P | |||
| Transurethral | ||||||||||
| Intraoperative (specify) (6) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
Mary S Patel
Division Sign-Off
Division of Radiological Devices
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
510K
[6] Intraoperative includes abdominal, thoracic and peripheral;
["] Coded Pulse is for digitally encoded harmonics.
(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
[] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[] Coded Pulse is for digitally encoded harmonics.
(PLEASED ON NOT WRITE BELOW THIS LINE _ CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 8L-RS Transducer
Mode of Operation Other Power Combined Harmonic Coded Clinical Application PW CW Color Color M B M Imaging Pulse Doppler Modes Doppler Doppler Doppler Doppler Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P Abdominal™ P P P P P P P P P Pediatric P P P P P P Small Organ 121 P P P P P Neonatal Cephalic Adult Cephalic Cardiac [3] P P P P P P P P P P P P P Peripheral Vascular P P P P P P P P P Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural(specify) [4] Other 151 Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethral Intraoperative (specify) (6) P P P P P P P Intraoperative Neurological Intravascular Laparoscopic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
Mory Spath
(Division Sign-Off)
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Satety
510K
[6] Intraoperative includes abdominal, thoracic and peripheral; [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] Coded Pulse is for digitally encoded harmonics.
['] 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)
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GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 9L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse* | Other |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal [1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ [2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | |||
| Thoracic/Pleural(specify) [4] | N | N | N | N | N | N | N | N | |||
| Other [5] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify) [6] | P | P | P | P | P | P | P | P | |||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] For detection of fluid and pleural motion/sliding;
- [5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral; 610K
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics.
Image /page/12/Figure/12 description: The image shows a signature, presumably of a person. The signature appears to read "Mary Stott". Below the signature is the text "(Division Sign-Off)" in a smaller font size. A horizontal line is drawn beneath the signature and above the text.
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{13}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application CW Color Color M Power Combined Harmonio Coded PW B M Imaging Pulse Doppler Doppler Dopple Modes Doppler Doppler Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics N N N N N N Abdominal N N P P P P P Pediatric P P P Small Organ 121 P P P P P P P P Neonatal Cephalic Adult Cephalic Cardiac P P P P P Peripheral Vascular P P P P P Musculo-skeleta! P P P P P P Conventional Musculo-skeletal P P P P P P P P Superficial Thoracic/Pleural(specify) (41 P P P P P P P P Other (specify) [3] Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethrai Intraoperative(specify) 161 Intraoperative Neurological Intravascular Laparoscopic N = new indication; P = previously cleared by FDA; E = added under Appendix E
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[5] Other use includes Urology/Prostate
Mary Stastil
610K
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
[6] Intraoperative includes abdominal, thoracic and peripheral;
[*] Combined modes are B/M. B/PWD. B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics.
(19).E.A.SE.D.O.NOT WRITE.BELOW THIS LINE_CONTINUE.ON ANOTHER JAGE (ENEFOD)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{14}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 16L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse* |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | ||||||||||
| Abdominal | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ [2] | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | ||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | P | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P | P | ||
| Thoracic/Pleural(specify)[4] | ||||||||||
| Other (specify) [5] | ||||||||||
| Exam Type, Means ofAccess | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intraoperative(specify) [6] | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic | ||||||||||
| N = new indication; P = previously cleared by FDA; E = added under Appendix ENotes: [1] Abdominal includes GYN and Urological[2] Small organ includes breast, testes, thyroid.[3] Cardiac is Adult and Pediatric.[4] For detection of fluid and pleural motion/sliding;[5] Other use includes Urology/Prostate |
HURST PI
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
・・
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
[6] Intraoperative includes abdominal, thoracic and peripheral; [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] Coded Pulse is for digitally encoded harmonics.
{15}------------------------------------------------
GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with i12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse* | Other |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ [2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | P | P | P | P | P | P | ||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P | ||||
| Thoracic/Pleural(specify)[4] | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | P | P | P | P | P | P | P | ||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | |||||||||||
| Notes: [1] Abdominal includes GYN and Urological | |||||||||||
| [2] Small organ includes breast, testes, thyroid. | |||||||||||
| [3] Cardiac is Adult and Pediatric. | |||||||||||
| [4] For detection of fluid and pleural motion/sliding; | |||||||||||
| [5] Other use includes Urology/Prostate | |||||||||||
| [6] Intraoperative includes abdominal, thoracic and peripheral;[] Combined modes are B/M, B/PWD,B/Color/PWD, B/Power/PWD.[] 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)
{16}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with i/t739-RS Transducers
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ [2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | P | P | P | P | P | P | P | |||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Thoracic/Pleural(specify)[4] | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | P | P | P | P | P | P | P | P | |||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P = previously cleared by FDA; E = added under Appendix E | |||||||||||
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | 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 [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| 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 | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Thoracic/Pleural(specify)[4] | P | P | P | P | P | P | P | P | P | P | P |
| Other[5] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| N = new indication; P = previously cleared by FDA; E = added under Appendix ENotes: [1] Abdominal includes GYN and Urological[2] Small organ includes breast, testes, thyroid.[3] Cardiac is Adult and Pediatric.[4] For detection of fluid and pleural motion/sliding;[5] Other use includes Urology/Prostate[6] Intraoperative includes abdominal, thoracic and peripheral;[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD. | |||||||||||
| Clinical ApplicationAnatomy/Region of Interest | Mode of Operation | ||||||||||
| B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Thoracic/Pleural(specify)[4] | |||||||||||
| Other[5] | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic | |||||||||||
| Clinical ApplicationAnatomy/Region ofInterest | Mode of Operation | Other | |||||||||
| B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse* | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | ||||||||||
| Peripheral Vascular | P | ||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Thoracic/Pleural (specify)[4] | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
minal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
Mam S. Postl
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sellety
Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral; [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
["] Coded Pulse is for digitally encoded harmonics.
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113690
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{17}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 3S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{18}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Image /page/18/Figure/4 description: The image shows a line of text that reads "(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)". The text is in all caps and is underlined. The purpose of the text is to instruct the reader not to write below the line and to continue on another page if needed.
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
{19}------------------------------------------------
GE Compact Ultrasound LOGIO i, LOGIO e, Vivid e with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[1] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD, B/Power/PWD, 10/2
- "] Coded Pulse is for digitally encoded harmonics.
Mary S. Patel
(Division Sign-Off)
Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
igitally 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)
{20}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIO e, Vivid e with 6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse* | Other |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal (1) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac (3) | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Thoracic/Pleural (specify) (4) | |||||||||||
| Other (5) | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify) (6) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral;
Mary S Pastel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113690
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] 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)
{21}------------------------------------------------
GE Compact Ultrasound LOGIQ i, LOGIQ e, Vivid e with L8-18i-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region ofInterest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N |
| Small Organ [2] | N | N | N | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletalConventional | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | N | N | N | N |
| Thoracic/Pleural(specify)[4] | N | N | N | N | N | N | N | N | N | N | N |
| Other[5] | |||||||||||
| Exam Type, Means ofAccess | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify)[6] | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
previously cleared by FDA; E indication; F
Notes: [I] Abdominal includes GYN and Urological
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[6] Intraoperative includes abdominal, thoracic and peripheral; 510K
[*] Combined modes are B/M. B/PWD, B/Color/PWD, B/Power/PWD,
[*] Coded Pulse is for digitally encoded harmonics.
Mace S. Patil
(Division Sign-Off)
Division of Rediological Devices Offica of In Vitro Diagnostic Device Evaluation and Safaty
(PLEASE DO NOT WRITE BELOW THIS LINE_CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
§ 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.