(30 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular (PV), Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transvaginal (TV), and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter weight package.
This document describes the Summary of Safety and Effectiveness for the GE Vivid E9 Ultrasound system, prepared in accordance with 21 CFR Part 807.92(c).
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Vivid 7 Diagnostic Ultrasound) rather than establishing specific quantitative acceptance criteria for device performance. The "acceptance criteria" are implied to be adherence to medical device safety standards and comparable performance to the predicate.
The table below summarizes the claimed performance characteristics and indications for use, noting that these are "previously cleared by FDA" (P) or "new indication" (N) for specific transducers. The core acceptance criterion for the device itself is its safety and effective performance, which is stated to be consistent with traditional clinical practice and FDA guidelines.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with applicable medical device safety standards. | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. |
| Consistent with traditional clinical practice and FDA guidelines | 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, ISO 9001:2000 and ISO 13485 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. |
| Substantial equivalence to predicate device (GE Vivid 7) | The GE Vivid E9 is of a comparable type and substantially equivalent to the current GE Vivid 7 with overall enhanced performance in a smaller and more compact package. It has the same overall characteristics, key safety and effectiveness features, physical design, general overall construction, and materials, and has the same intended uses and operating modes as the predicate device. |
| Indications for Use (Per Transducer) | (Each "P" or "N" in the following tables indicates claimed performance for that mode/application) |
| GE Vivid E9 Ultrasound System (Overall) | Clinical applications: Ophthalmic, Fetal/Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Intraoperative (abdominal, thoracic, & vascular). All listed modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, RT3D Mode) are claimed as 'P' for most applications, except for harmonic imaging, which is not universally 'P' across all applications. Notably, Intraoperative is 'N' for Coded Pulse. |
| GE Vivid E9 with 4C-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Peripheral Vascular (P), Urology (P). All listed modes except CW Doppler are 'P' for these applications. Harmonic Imaging is 'P' for all except Urology, which is blank for Harmonic. |
| GE Vivid E9 with 9L-D Transducer | Pediatric (P), Small Organ (P), Peripheral Vascular (P), Musculo-skeletal Conventional (P). All listed modes except CW Doppler are 'P' for these applications. |
| GE Vivid E9 with 11L-D Transducer | Pediatric (N), Small Organ (N), Peripheral Vascular (N), Musculo-skeletal Conventional (N), Intraoperative (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with M4S-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Adult Cephalic (P), Cardiac (P), Other[Urology/Prostate] (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with M5S-D Transducer | Fetal/Obstetrics (N), Abdominal (N), Pediatric (N), Adult Cephalic (N), Cardiac (N), Other[Urology/Prostate] (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with 6S-D Transducer | Fetal/Obstetrics (N), Abdominal (N), Pediatric (N), Neonatal Cephalic (N), Cardiac (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with 3V-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Adult Cephalic (P), Cardiac (P), Other [Urology/Prostate] (P). All listed modes including CW Doppler, RT3D Mode, Combined Modes, Harmonic, and Coded Pulse are 'P' for these applications. |
| GE Vivid E9 with E8C-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Other[Urology/Prostate] (P), Transrectal (P), Transvaginal (P). All listed modes except CW Doppler and Harmonic Imaging are 'P' for these applications. |
| GE Vivid E9 with 6T or 6Tc Transducer | Cardiac (P), Transesophageal (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with 9T Transducer | Cardiac (P), Transesophageal (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with P2D Transducer | Cardiac (P) and Peripheral Vascular (P) for PW Doppler and CW Doppler modes only. Other modes are not specified. |
| GE Vivid E9 with P6D Transducer | Cardiac (P) and Peripheral Vascular (P) for PW Doppler and CW Doppler modes only. Other modes are not specified. |
Study Details:
A formal clinical study to prove the device meets acceptance criteria was not required or performed for this 510(k) submission.
-
1. A table of acceptance criteria and the reported device performance: See table above.
-
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set was used, as clinical tests were stated as "None required."
- Therefore, no sample size, data provenance, or retrospective/prospective nature of the data is reported.
-
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, as no clinical test set was utilized and no ground truth was formally established for direct comparison of the new device's performance against clinical outcomes. The equivalence relies on the established safety and efficacy of diagnostic ultrasound and its predicate.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set was utilized.
-
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:
- No MRMC comparative effectiveness study was done. This submission is for an ultrasound imaging system, not an AI-powered diagnostic aid. The device is a diagnostic ultrasound system, and the submission emphasizes its substantial equivalence to a predicate device and adherence to safety standards, not an improvement in human reader performance through AI assistance.
-
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a diagnostic ultrasound system that requires human operation, not a standalone AI algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new ground truth for performance evaluation was established for this submission, as clinical tests were not required. The "ground truth" for the device's acceptable safety and effectiveness is implied through its adherence to established medical device safety standards and the long history of safe and effective performance of diagnostic ultrasound as a modality.
-
8. The sample size for the training set:
- Not applicable. This device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
-
9. How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model was used.
{0}------------------------------------------------
$\times 081921/
AUG - 6 2008
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Section a):
| 1. | Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414, Milwaukee, WI 53201 |
|---|---|---|
| Contact Person: | Allen Schuh,Manager, Ultrasound Regulatory AffairsTelephone: 414-721-3992; Fax: 414-721-3899 | |
| Date Prepared: | July 2, 2008 | |
| 2. | Device Name: | GE Vivid E9 UltrasoundUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| 3. | Marketed Device: | GE Vivid 7 Diagnostic Ultrasound K003931/K031663/K041552/K051449/K060542 |
Device Description: The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and র্ব analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter
(90-IYO/IYN/ITX) A device currently in commercial distribution.
-
Indications for Use: The device is intended for ultrasound evaluation of Fetal: Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
-
Comparison with Predicate Device: The GE Vivid E9 is of a comparable type and substantially equivalent to the current GE Vivid 7 with overall enhanced performance in a smaller and more compact package. It has the same overall characteristics, key safety and effectiveness features, physical design, general overall construction, and materials, and has the same intended uses and operating modes as the predicate device.
Section b):
weight package.
-
Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
-
Clinical Tests: None required.
-
Conclusion: Intended uses and other kev 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, ISO 9001:2000 and ISO 13485 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 GE Vivid 7 BT06 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Allen Schuh UG - 6 2009 Regulatory Affairs Manager General Electric Co. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226
Re: K081921
Trade/Device Name: GE Vivid E9 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: July 2, 2008 Received: July 7, 2008
Dear Mr. Schuh:
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 Vivid E9 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C-D | 3V-D |
|---|---|
| 9L-D | E8C-D |
| 11L-D | 6T or 6Tc |
| M4S-D | 9T |
| M5S-D | P2D |
| 6S-D | P6D |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any
{2}------------------------------------------------
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 (08) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information. including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Herbert Lehman
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 Ultrasound System
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 | RT3DMode* | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | P | |
| 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] | 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 | P | |
| Other[4] | P | 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 | P | P | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | P | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | ||
| Transuretheral | P | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative[5] | P | P | P | P | P | P | P | P | N | P | P | |
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
12:5
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV),
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510((k) Number __
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Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 4C-D 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 |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | |
| Small Organ[2] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | |
| 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 | ||||||||||
| Transuretheral | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Helena
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 9L-D 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 | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| 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 | |||||||||||
| Other [4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 11L-D 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 | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[5] | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hish
Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081921
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with M4S-D 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 | Modes | Combined HarmonicImaging | CodedPulse | ||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | p | P | P | P | P | P | P | P | ||
| Abdominal | 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 | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | ||
| Cardiact31 | P | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P | b | P | P | P | P | P | P | b | P | ||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE),
vice Evaluation (ODE)
Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with M5S-D 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 | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other [4] | N | N | N | N | N | N | N | N | N | N | |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Sitem
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{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 6S-D 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 |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N |
| Abdominal | N | N | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N | N | N |
| Small Organ[2] | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | ||||||||||
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other[4] | ||||||||||
| Exam Type, Means of Access | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vice Evaluation (ODE)
Sign-Off)
(Division Sign-Utt)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081921
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 3V-D 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 | RT3DMode* | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | 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 | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other [4] | P | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
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Helena
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Division of Reproductive, Abdominal and Radiological Device 510(k) Number
{11}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with E8C-D 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 |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | ||
| Abdominal[1] | P | P | P | P | 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 | ||
| Exam Type, Means of Access | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | P | P | P | P | P | P | P | P | ||
| Transvaginal | P | P | P | P | P | P | P | P | ||
| Transuretheral | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helu
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number L081924
{12}------------------------------------------------
.. .
: 1 : 1
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 6T or 6Tc 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 | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| 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; E = added under Appendix E
Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helu
Sign-Off
Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 9T 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 | |
| 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 (specify) | |||||||||||
| 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; E = added under Appendix E
Notes: [1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[3] Cardiac is Adult & Pediatric
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription User (Per 21 CFR 801.109)
E-12
{14}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with P2D 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 | |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | P | P | |||||||||
| Peripheral Vascular | P | P | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [3] Cardiac is Adult and Pediatric. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{15}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with P6D 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 | Combined Modes | HarmonicImaging | CodedPulse |
| Ophthalmic | ||||||||||
| Fetal / Obstetrics | ||||||||||
| Abdominal | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac[3] | P | P | ||||||||
| Peripheral Vascular | P | P | ||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| Exam Type, Means of Access | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transuretheral | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [3] Cardiac is Adult and Pediatric.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Prescription User (Per 21 CFR 801.109)
}
§ 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.