VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
Device Facts
| Record ID | K132913 |
|---|---|
| Device Name | VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Nov 8, 2013 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric: Small Organ (breast, testes, thyroid etc.): Neonatal and Adult Cephalic: Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal
Device Story
Voluson E-Series (E6/E8/E8Expert/E8Expert LE/E10) is a mobile, cart-based diagnostic ultrasound system for general radiology and OB/GYN. It features real-time 3D/4D acquisition capabilities. The system includes a console, keyboard, touch panel, and display. It supports various linear, curved, and matrix phased array transducers for standard imaging modes (B, M, PW/CW Doppler, Color/Power Doppler). Operated by clinicians in clinical settings, it provides high-performance imaging and analysis with DICOM networking. Output is visualized on the system display to assist in clinical decision-making, such as fetal monitoring, biopsy guidance, and elastography. Benefits include enhanced diagnostic visualization for obstetric, cardiac, and vascular assessments.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device was evaluated through non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993-1).
Technological Characteristics
Mobile console with keyboard, touch panel, and display. Utilizes linear, curved, and matrix phased array transducers (mechanical and electronic scanning). Supports B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging, and 3D/4D modes. Connectivity via DICOM. Biocompatible patient-contact materials. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, and ISO 10993-1.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, and Musculoskeletal applications. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- Voluson E-Series E6/E8/E8Expert/E8Expert LE/E10 Diagnostic Ultrasound System (K131267)
Related Devices
- K122327 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Sep 21, 2012
- K131267 — VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 · GE Healthcare · Jun 19, 2013
- K113758 — VOLUSON E6/E8/E8EXPERT/E10 · GE Healthcare · Jan 10, 2012
- K101236 — VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM · GE Healthcare · Feb 8, 2011
- K181985 — Voluson E6, Voluson E8, Voluson E10 · GE Healthcare · Nov 15, 2018
Submission Summary (Full Text)
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K132913
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## 510(k) Summary
| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 16, 2013 |
| Submitter: | GE Healthcare [GE Healthcare Austria GmbH & Co OG]<br>Tiefenbach 15<br>Zipf, Austria 4871 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:(414)721-4214<br>F:(414)918-8275 |
| Secondary Contact Person: | Roland Kuntscher<br>Regulatory Affairs Specialist<br>GE Healthcare Austria GmbH & Co OG<br>T:(++43)7682-3800-660<br>F:(++43)7682 3800-47<br>NOV 0 8 2013 |
| Device:<br>Trade Name: | Voluson E Series |
| | Models: Voluson E6/E8/E8Expert/E8Expert Limited Edition/<br>E10 Diagnostic Ultrasound Systems |
| Common/Usual Name: | Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN<br>Ultrasonic Pulsed Echo Imaging System. 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer. 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K131267 Voluson E-Series E6/E8/E8Expert/E8Expert LE/E10<br>Diagnostic Ultrasound System |
| Device Description: | The Voluson E-Series system is a full-featured Track<br>ultrasound system, primarily for general radiology use and<br>specialized for OB/GYN with particular features for realtime<br>3D/4D acquisition. It consists of a mobile console with keyboard<br>control panel; color LCD/TFT touch panel, color video display<br>and optional image storage and printing devices. It provides high<br>performance ultrasound imaging and analysis and has<br>comprehensive networking and DICOM capability. It utilizes a<br>variety of linear, curved linear, matrix phased array transducers<br>including mechanical and electronic scanning transducers, which<br>provide highly accurate realtime three dimensional imaging<br>supporting all standard acquisition modes. |
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### GE Healthcare
510(k) Premarket Notification Submission
#### Device Modification:
This modification consists of a change to the labeling for the previously cleared SonolT feature. Additionally. the previously cleared probe RAB4-8-D had been re-introduced to the Voluson E Series and a correction to the transducer application Obstetrics on the 91 -D have been made since the previous clearance.
Intended Use:
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric: Small Organ (breast. testes, thyroid etc.): Neonatal and Adult Cephalic: Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal
The Voluson E-Series employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson E-Series and its applications comply with voluntary standards:
- 1. IEC60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety
- 2. IEC60601-1-2. Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 3. IEC60601-2-37. Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 4. NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 5. ISO10993-1. Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- 6. NEMA UD 2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
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K132913
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## GE Healthcare
510(k) Premarket Notification Submission
- 7. ISO14971. Application of risk management to medical devices
- 8. NEMA. Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- Requirements Reviews ●
- Design Reviews ●
- . Testing on unit level (Module verification)
- Integration testing (System verification) .
- Final Acceptance Testing (Validation) 0
- . Performance testing (Verification)
- Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
#### Summary of Clinical Tests:
The subject of this premarket submission. Voluson E Series, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the Voluson E Series to be as safe. as effective, and performance is substantially equivalent to the predicate device(s).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 8, 2013
GE HEALTHCARE BRYAN BEHN REGULATORY AFFAIRS MANAGER 9900 W INNOVATION DRIVE WAUWATOSA WI 53226
Re: K132913
Trade/Device Name: Voluson E6 / F8 / E8expert / E8expert Limited Edition / E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 22, 2013 Received: October 24, 2013
Dear Mr. Behn:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Yoluson E6 / E8 / E8expert / E8expert Limited Edition / E10 Diagnostic Ultrasound Systems, as described in your premarket notification:
| | Transducer Model Number | |
|------------|-------------------------|----------|
| RAB2-2-D | (21) | 3Sp-D |
| RIC5-9-1) | P6D | C4-8-D |
| RNA5-9-1) | I I L-D | RAB6-D |
| 4C-D | CI-5-ID | eM6C |
| ICS-9-1) | MIL.6-15-ID | S4-10-D |
| रऽP6-16-D | RM6C | RAB4-8-D |
| RIC6-12-12 | RRES-10-D | |
| 9L-D | RM 41. | |
| | | |
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Page 2-Mr. Behn
If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/Resources/or You/Industry/default.htm. 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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### 510(k) Number (if known): K132913
Device Name: Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10) Diagnostic Ultrasound Systems
Indications for Use:
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development): Pediatric: Small Organ (breast, testes, thyroid etc.): Neonatal and Adult Cephalic: Cardiae (adult and pediatric): Musculoskeletal Conventional and Superficial: Peripheral Vascular: Transvaginal: Transrectal
Preseription Use - X -(Part 21 CFR 801 Subpart D) ANDJOR
Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)
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### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E Series system and for all of its probe/mode combinations. Combinations identified as "P" represents those previously cleared with the unmodified Voluson E6/E8/E8ExperVE10 and "E" arc those that have been added by Appendix E of the FDA Ultrasound guidance. This modification did not add to the previously cleared system level or transducer indications or clinical applications.
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Image /page/7/Picture/0 description: The image shows a black and white logo. The logo is circular and contains a stylized monogram of the letters 'G' and 'E'. The letters are intertwined and surrounded by a decorative border. The logo appears to be a vintage or classic design.
#### Diagnostic Ultrasound Indications for Use Form GE Voluson E-Series (Voluson E6/E8/E8Expert/E8Expert Limited Edition/E10)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
' .
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [ 5 ] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | [ 5 ] |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[1] | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [ 5,6,9 ] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
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, salivary gland, lymph nodes, pediative and neonatal patients [3] Cardiac is Adull and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prosiate.
(9) Elastography imaging- Elasticity
(' ) Combined modes are B/M. B/Color M, B/PWD or CWD. B/Color/PWD or CWD. B/Power/PWD.
(*) 4D color Doppter
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### Diagnostic Uitrasound Indications for Use Form GE Voluson E Series with RAB2-5-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy-Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics1 | P | P | P | P | P | P | P | P | P | P | [5, 6] |
| Abdominal1 | P | P | P | P | P | P | P | P | P | P | [5, 6] |
| Pediatric | | | | | | | | | | | |
| Small Organ1 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac1 | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5, 6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication. P = previously cleared by FDA: E = added under Appendix E
Notes: [ ] ] Abdominal includes tenal. GYN/Pelvic
(5) 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (3D/4D)
[7] Includes infertility monitoring of follicle development
| * | Combined modes are B/M. B/Color M, IV/W1) or CW1), B/Color/PW1) or CWD, B/Poster/PW1D
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#### Diagnostic Ultrasound Indications for Use Form
### GE Voluson E Series with RIC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics1 | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| AbdominalII | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small OrganII | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| CardiacII | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| TransrectalII | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5,6,9] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication, P = previously cleared by FDA. E = added under Appendix fr
[5] 3D/4() Imaging Mode Nolcs
[6] Includes amaging of guidance of bropsy (3D-40)
| 7 | Includes inferritity monitoring of follicle development
|8| Includes urology/prostate
19) Elastography Imagings Masticity
1° | Combined modes are IVM, BC ulor M, HiPWD or CWD, B/Color?PWD or CWD, B/Power/PWD.
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#### Diagnostic Ultrasound Indications for Use Form
#### GE Voluson E Series with RNA5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|----------------|------------------|--------------------|------------------|-------|-------------------------------|----------------|------------------|
| Clinical Application<br>Anatomy Region of Interest | B | M | PW<br>Doppler | ("W<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Depoter | Modes | ombined I larmonic<br>Imaging | Coded<br>Pulse | Olber<br>(Nolcs) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obsteiries!" | P | P | P | 12 | P | P | p | P | P | P | 2.6) |
| Abdominal 11 | P | P | P | P | P | P | P | P | P | b | રુંદર્ણ |
| l'ediatric | P | P | P | P | P | P | P | P | P | P | 2.6 |
| Small Organia | P | P | P | မြ | P | r | ગુજર | P | r | ្រ | િર્મ્ણ |
| Neonatal Cophalic | P | P | P | P | b | P | P | P | P | P | ા રા |
| Adult Cephalic | | | | | | | | | | | |
| ייבוליתונו } | P | P | ll | P | P | P | P | P | P | ប្រ | રો |
| Peripheral Vascular | P | p | P | 12 | P | P | p | P | P | p | ા રજકો |
| Musculo-skeletal Conventional | P | P | P | P | P | P | p | P | P | b | 5.6) |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exem Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectol™ | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| I ransuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravoscular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under Appendix E
| | | Abdominal is Nennatal and pediatric Norts:
[2] Small organ includes breast, thyroid, suivary gland, I mph nodes, pediatric and nennation patients
[3] Cardiac is Neonatal and Pediatric
{ } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }
[6] Includes imaging of guidance of biopsy (31)/4())
[*] Combined modes are 13/M, B/Color M, B/PW1) or CWD, B/C'olor/PW1D or C'WD, WPower/PW12.
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.
### Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 4C-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|----------------|
| Clinical Application<br>Anatomy: Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>Notes |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | P | P | P | P | P | P | P | [6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [6] |
| Pediatric | | | | | | | | | | | |
| Small Organ[1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes renal. GYN/Pelvic. Urology Notes:
16] Includes imaging of guidance of hiopsy (20)
| 7 | Includes infectility monitoring of follicle development
| * | Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD,
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Image /page/12/Picture/0 description: The image shows a logo with the letters 'GE' intertwined inside a circle. The letters are stylized and appear to be handwritten or calligraphic. The circle has a textured or patterned border, giving it a slightly rough or organic look. The logo is black and white, with the letters and border in black against a white background.
### Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy: Region of Interest | Mode of Operation | | | | | | | | | | | Other<br>[Notes] |
|-----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [6,9] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication: P = previously cleared by FI>A: 1 = added under Appendix E
[6] Includes maging of goldance of hiopsy (20) Notes
| 7 | Includes infertitity monnoring of follicle development
| 8| Includes urology/prostate
|9} Elastography Imaging. Hiasticus
| * | Combined modes are B/M, B/Color M, B/PWD or CWD, IWC olor/PWD or CWD, B/Power/PWD,
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{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The intertwined letters are enclosed within a circular border. The logo is black and white.
#### Diagnostic Ultrasound Indications for Use Form
### GE Voluson E Series with RSP6-16-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|-----------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics1 | | | | | | | | | | | |
| Abdominal1 | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [5,6] |
| Small Organ1 | P | P | P | | P | P | P | P | P | P | [5,6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac1 | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [5,6] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [5,6] |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal1 | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication, P = previously cleared by FDA: E = udded under Appendiv E
12) Small organ includes breast, thyroid, salivary gland, lymph nodes, pechairie and neonatal patients Notes
|5) 31)/41) Imaging Mode
[6] Includes imaging of guidance of hiopsy (3D/4D)
[*] Combined modes are B/M, B/Calor M. B/PW1) or CWD, B/Calor/PW1) or CWD, B/Power/PWD
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Image /page/14/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined in the center. The letters are stylized and have a vintage look. The logo is likely for General Electric (GE).
# Diagnostic Ultrasound Indications for Use Form
### GE Voluson E Series with RIC6-12-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | [5, 6] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[1] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[1] | P | P | P | | P | P | P | P | P | P | [5, 6] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [5, 6] |
| Transuretherul | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication, I' = previously cleared by FDA. E = added under Appendix F.
Notes: [5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of hiopsy (3D/4D)
[7] Includes infertility monitaring of follicle development
[8] Includes urology/prosunc
[*] Combined modes are R/M, I3/Color M, HJ/WD or CWI), HXColor/PWI) or CWD, B/Power/PW/D.
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Image /page/15/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are surrounded by a decorative border, giving the logo a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form GE Voluson E Series with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | E | E | E | E | E | E | E | E | E | E | [6] |
| Abdominal | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6] |
| Small Organ | P | P | P | P | P | P | P | P | P | P | [6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [6] |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | |…
