← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K033139
# GE MARLIN ULTRASOUND (K033139)
_General Electric Co. · IYN · Oct 23, 2003 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K033139
## Device Facts
- **Applicant:** General Electric Co.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Oct 23, 2003
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
## Device Story
GE Marlin is a compact, portable echocardiography and general imaging ultrasound system. It utilizes interchangeable electronic array transducers to acquire ultrasound signals, which are processed to produce real-time diagnostic images and fluid flow analysis. Operated by physicians in clinical settings, the device provides visual output for diagnostic evaluation of various anatomical regions. It functions similarly to the predicate GE Vivid 3, maintaining identical imaging capabilities while offering enhanced portability. The system aids clinical decision-making by enabling non-invasive visualization of internal structures and hemodynamics, facilitating diagnosis and patient management.
## Clinical Evidence
No clinical data required. Bench testing performed, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing. Device conforms to applicable medical device safety standards.
## Technological Characteristics
Compact, portable ultrasound system. Uses interchangeable electronic array transducers. Supports B-mode, M-mode, PW/CW Doppler, Color Doppler, Color M-Doppler, Power Doppler, and Harmonic Imaging. Conforms to 21 CFR 820, ISO 9001, and ISO 13485. Connectivity via interchangeable transducers.
## Regulatory 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
- GE Vivid 3 Ultrasound System ([K020789](/device/K020789.md))
## Reference Devices
- GE LOGIQ Book
## Submission Summary (Full Text)
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K033139
# Attachment B
# Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular shape. The circle has decorative swirls or flourishes around the perimeter, giving it a distinctive and recognizable appearance. The logo is black and white.
GE Ultrasound
GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue Milwaukee, WI 53219
#### Section a):
| Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC
PO Box 414
Milwaukee, WI 53201 |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,
Manager, Safety and Regulatory Engineering
Telephone: 414-647-4385; Fax: 414-647-4090 |
| Date Prepared: | September 29, 2003 |
2. Device Name: GE Marlin Diagnostic Ultrasound System.
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝ
3. Marketed Device: GE Vivid 3 Ultrasound System,
510(k) Number K020789, a device currently in commercial distribution.
4. Device Description: The GE Marlin is a full featured echocardiography system in a highly compact and portable package. It has a full complement of interchangeable electronic array transducers giving it additional capability in general imaging. Although this modificantly changes the size and packaging of the device, it does retain the same intended use and overall imaging capability as the unmodified GE Vivid 3
5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
6. Comparison with Predicate Device: The GE Marlin is a comparable type and substantially equivalent to the unmodified Vivid 3 in terms of intended use and clinical utility. Additionally, it is comparable to the GE LOGIQ Book with respect to physical size and portability. The Marlin shares the same technological characteristics, overall design, construction methods and materials as the predicate devices. Transducers are already cleared for use with the predicate devices and other GE ultrasound systems or utilizes the same materials and construction.
#### Section b):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
#### 2. Clinical Tests: None required.
3. Conclusion: 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 Quality System Regulation and ISO 9001 & 13485 quality system standards for medical device manufacturers. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing production surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Marlin Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market
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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 representation of a human figure in profile, with three faces overlapping to suggest a sense of community and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2003
Mr. Allen Schuh Manager, GE Ultrasound Product Safety and Regulatory Compliance GE Medical Systems Ultrasound and Primary Care Diagnostic, LLC 4855 West Electric Avenue MILWAUKEE WI 53219
Re: K033139
Trade Name: GE Marlin Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic trasducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 29, 2003 Received: September 30, 2003
#### 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 Marlin Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
#### 3C-RS 8C-RS
{2}------------------------------------------------
E8C-RS
8L-RS
i12L-RS
i/t739-RS
3S-RS
7S-RS
10S-RS
6T-RS
9T-RS
P2D
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 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 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
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Page 3 - Mr. Schuh
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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Segner
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 Marlin Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (specify)[2] | P | P | P | P | P | P | P | P | P | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | P | P | P | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division Sign-Off) n of Reproductive, Abdominal, and Radiological Devi
Prescription User (Per 21 CFR 801.109)
{5}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 3C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | | N | | N | N | N | | |
| Abdominal[1] | N | N | N | | N | | N | N | N | | |
| Pediatric | N | N | N | | N | | N | N | N | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | N | N | N | | N | | N | N | N | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
David A. Hyman
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number
{6}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | N | N | N | | N | | N | N | N | | |
| Pediatric | N | N | N | | N | | N | N | N | | |
| Small Organ (specify)[2] | N | N | N | | N | | N | N | N | | |
| Neonatal Cephalic | N | N | N | | N | | N | N | N | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | | N | N | N | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Iaparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yamil A. Lynn
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices
Prescription User (Per 21 CFR 801.109)
{7}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--|-------------------|---------------------|----------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | N | N | | N | | N | | N | N | | |
| Abdominal[1] | N | N | N | | N | | N | | N | N | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | N | N | N | | N | | N | | N | N | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | N | N | N | | N | | N | | N | N | | |
| Transvaginal | N | N | N | | N | | N | | N | N | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | | |
| 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.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Dealer Evaluation (ODE)
Daniel A. Lyon
(Division gn-Off Division of Reproductive, Abdominal. and Radiological I 510(k) Number
{8}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 8L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | N | N | N | | N | | N | N | N | | | |
| Pediatric | N | N | N | | N | | N | N | N | | | |
| Small Organ (specify)[2] | N | N | N | | N | | N | N | N | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | | N | N | N | | | |
| Musculo-skeletal Conventional | N | N | N | | N | | N | N | N | | | |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | | | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic.
[3] Cardiac is Adult and Pediatric.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
---
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
{9}------------------------------------------------
#### Diaqnostic Ultrasound Indications for Use Form
# GE Marlin with i12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ (specify)[2] | 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 | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN.
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Szymm
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with i/t739-RS Transducers
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | | P | | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: J3] Cardiac is Adult and Pediatric via intraoperative.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sygm
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological D 510(k) Number
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 3S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Cardiac[3] | 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 | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| l anarosconic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
David A. Segeen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
Prescription User (Per 21 CFR 801.109)
Radiological Devices
K133124
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 7S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|-------|--|
| Clinical Application
Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | | |
| Small Organ (specify)[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | 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 | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(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 | K033139 |
Prescription User (Per 21 CFR 801 109)
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 10S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sezem
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number
{14}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE Marlin with 6T-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify)[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
Prescription User…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K033139](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K033139)
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