(58 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms in the device description or intended use. The focus is on the hardware and basic ultrasound functionalities.
No.
The device is described as a "general purpose diagnostic ultrasound imaging system" and its intended uses are for "visualization and measurement of anatomical structures and fluid" and for "clinical diagnosis purposes" and "procedural guidance," not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Vscan with Dual Probe is general purpose diagnosic ultrasound imaging system". Additionally, the "Device Description" section reiterates "Vscan with Dual Probe is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system." The text also states, "The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes". Furthermore, the "Predicate Device(s)" section lists other predicate devices as "Diagnostic Ultrasound System".
No
The device description explicitly states it is a "pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system" consisting of a "handheld unit with a flip up 3.5 inch LCD display and a permanently attached dual ended (phased and linear) transducer". This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vscan with Dual Probe is a diagnostic ultrasound imaging system. It uses sound waves to create images of internal anatomical structures and fluid within the body. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use clearly states it's for "visualization and measurement of anatomical structures and fluid" and for "imaging guidance" and "basic/focused assessments" and "adjunctively with other medical data for clinical diagnosis purposes." These are all applications of medical imaging performed directly on the patient.
The text describes a device that performs imaging on the patient, not tests on samples taken from the patient.
N/A
Intended Use / Indications for Use
Vscan with Dual Probe is general purpose diagnosic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications:
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e,g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, amniocentesis), Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics
Its pocket-sized portability and simplified user integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during, triage assessments, and procedural guidance for adults and pediatrics.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Vscan with Dual Probe is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a flip up 3.5 inch LCD display and a permanently attached dual ended (phased and linear) transducer operating B and color modes with digital acquisition, processing and display capability. The user interface control panel is composed of a navigation wheel that allows for intuitive thumb control. The battery can be charge either in the system or alone. The system contains a Docking Station, charger with cable and soft bag. Capabilities also include distance measurements, voice recordings and storage of files. Additional Vscan gateway software can be loaded on a personal computer to allow the user to review, annotate and create reports with the image, video and voice files once files are transferred using the included USB cable.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound
Anatomical Site
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular (lower extremity, carotid); Thoracic/Lung (pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints.
Indicated Patient Age Range
Adults and Pediatrics
Intended User / Care Setting
Qualified and trained health care professionals.
Examination and training sessions indoors and in other environments described in the user manual.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Vscan with Dual Probe, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
MAY 1 6 2014
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 15, 2014 |
|---|---|
| Submitter: | GE Healthcare |
| GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Vingmed Ultrasound AS |
| Strandpromenaden 45 | |
| Horten, Norway N-3183 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| F:(414)918-8275 | |
| Alternate Contact Person: | Bryan Behn |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| Device Trade Name: | Vscan with Dual Probe |
| Common Name: | Ultrasound system |
| Classification: | Class II |
| Classification Name / | |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, |
| 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Predicate Device(s): | Vscan Diagnostic Ultrasound System - K092756 |
| Vivid e Diagnostic Ultrasound System - K113690 | |
| Venue 40 Diagnostic Ultrasound System - K112122 |
Section 5-2
.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are white, set against a black background, creating a high-contrast design.
Technology: The Vscan with Dual Probe employs the same fundamental scientific technology as its predicate devices
Determination of Substantial Equivalence:
Comparison to Predicate Devices
The Vscan with Dual Probe system is substantially equivalent to the predicate devices with regard to intended use. imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
- The Vscan with Dual Probe and predicate Vscan system . have the same clinical intended use with the exception of Small Organ, Musculo-skeletal conventional, Vascular access and Nonvascular access. Small Organ, Musculoskeletal conventional clinical intended uses are substantially equivalent to Vivid e in K113690. Vascular access and nonvascular access intended uses are substantially equivalent to the intended use Venue 40 cleared in K112122.
- The Vscan with Dual Probe and predicate Vscan have the . same imaging modes.
- The Vscan with Dual Probe and predicate Vscan have the . same system display size and are battery powered.
- The deep scanning end of the transducer on Vscan with . Dual Probe is similar to the probe on Vscan cleared in K092756.
- The shallow scanning end of the transducer on Vscan with . Dual Probe is similar to the 81 -- RS probe used on and cleared with Vivid e in K113690.
- The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The Vscan with Dual Probe and predicate Vscan have similar capability in terms of performing measurements. capturing digital images, reviewing and reporting studies.
- The Vscan with Dual Probe and predicate systems have . been designed in compliance with approved electrical and physical safety standards.
2
Device Description: Vscan with Dual Probe is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a flip up 3.5 inch LCD display and a permanently attached dual ended (phased and linear) transducer operating B and color modes with digital acquisition, processing and display capability. The user interface control panel is composed of a navigation wheel that allows for intuitive thumb control.
The battery can be charge either in the system or alone. The system contains a Docking Station, charger with cable and soft bag. Capabilities also include distance measurements, voice recordings and storage of files. Additional Vscan gateway software can be loaded on a personal computer to allow the user to review, annotate and create reports with the image, video and voice files once files are transferred using the included USB cable.
Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac: Abdominal: Renal: OB/GYN: Urology: Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines. upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, thoracentesis. amniocentesis); Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics
lts pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, triage assessments, and procedural guidance for adults and pediatrics.
Intended Use:
3
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the inner part of the circle are black, while the outer part of the circle is white.
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 Vscan with Dual Probe and its applications will comply with voluntary standards:
- AAMI/ANSI ES60601-1 (includes IEC 60601-1), ' . Medical Electrical Equipment - Part 1: General Requirements for Safety
- . IEC60601-1-2.Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 1EC60601-2-37, Medical Electrical Equipment -. Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal . and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition
- . ISO14971. Application of risk management to medical devices
- NEMA UD 2, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews ●
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Performance testing (Verification) ●
- Safety testing (Verification) .
Transducer materials are biocompatible.
4
Image /page/4/Picture/0 description: The image shows the text "K140693 Page 5 of 5" in a handwritten style. The text is written in black ink on a white background. The numbers and letters are clearly legible, and the overall impression is that of a document page number.
Summary of Clinical Tests:
The subject of this premarket submission, Vscan with Dual Probe, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Vscan with Dual Probe to be as safe, Conclusion: as effective, and performance is substantially equivalent to the predicate device(s).
Image /page/4/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are filled with a dark color, likely black, contrasting with a lighter background, possibly white. The logo is a well-known corporate symbol.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, positioned above a wavy line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2014
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Ms. Tracev Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K140693
Trade/Device Name: Vscan with Dual Probe Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO. ITX Dated: March 19, 2014 Received: March 20, 2014
Dear Ms. Ortiz:
We have reviewed your 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 to 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 docs 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 Vscan With Dual Probe, as described in your premarket notification:
Transducer Model Number
G3S
G8L
If your device is classified (see above) into either class II (Special Controls) or class III (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.
6
Page 2-Ms. Ortiz
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor 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/MedicalDevices/Safety/Reportal?roblem/dcfault.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sinh.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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K 140693
Device Name Vscan with Dual Probe
Indications for Use (Describe)
Vscan with Dual Probe is general purpose diagnosic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications:
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e,g. Iower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, amniocentesis), Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics
Its pocket-sized portability and simplified user integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during, triage assessments, and procedural guidance for adults and pediatrics.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
FORM FDA 3881 (1/14)
8
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
9
Image /page/9/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined. The letters are stylized and appear to be handwritten. The logo is likely for General Electric.
Diagnostic Ultrasound Indications for Use Form Vscan with Dual Probe Ultrasound System
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 13 | Doppler Modes | Combined | Hannonic | |||||||||
| Imaging | ("oded | |||||||||||
| Pulsc | Other | |||||||||||
| Anatomy Region of Interest | M | li W | (.W | Color | Color | |||||||
| M | Power | Modes | ||||||||||
| Fetal/OB | N | N | N | N | ||||||||
| Abdominal™ | N | ਮ | N | N | ||||||||
| Pedialric | N | N | N | ನ | 1 | |||||||
| Small Organ'21 | N | N | N | |||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | N | N | N | N | ||||||||
| Cardiac Pediatric | N | N | N | N | ||||||||
| Peripheral Vascular 131 | N | ਨ | ನ | N | ||||||||
| Musculo-skeietal Conventionally | N | N | N | |||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural (3) | N | N | N | N | ||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophagcal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Laparoscopic | ||||||||||||
| Interventional Guidance | ||||||||||||
| Vascular Access16) | N | N | N | |||||||||
| Nonvascular 17 | N | N | N | N |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes Gynecology, Renal and Urology: Notes:
[2] Small Organ includes breast, testes, and thyroid:
[3) Peripheral Voscular includes arteries and veins:
(4) Musculo-skeletol Conventional includes long bone, hip and knee joint visualization:
[5] Thoracic/Pleural is pleural motion/sliding os well as fluid detection:
[6] Vascular Access includes intravenous, intro-arteriol, central and peripheral lines;
[7] Nonvascular is image guidance for freehand needle/catheter placement:
(*) Combined mode is B/Color.
iplease do not write below this line • continue on another page if needed)
Concurrence of CDRH, Office of in Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Section 4-5
10
Image /page/10/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
Vscan with Dual Probe with deep scanning transducer (G3S)
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy: Region of Interest | B | M | Doppler Modes | | | | | Combined
Modes | Harmonic
Imaging | Coded
Pulse | Other |
|-----------------------------------------------------|---|---|---------------|----|-------|------------|-------|-------------------|---------------------|----------------|-------|
| | | | PW | CW | Color | Color
M | Power | | | | |
| Fetal/OB | P | | P | | P | | | P | P | | |
| Abdominal[1] | P | | P | | P | | | P | P | | |
| Pediatric | P | | P | | P | | | P | P | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | P | | P | | P | | | P | P | | |
| Cardiac Pediatric | P | | P | | P | | | P | P | | |
| Peripheral Vascular[1] | P | | | | N | | | N | P | | |
| Musculo-skeletal Conventional[4] | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | P | | P | | P | | | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access[6] | | | | | | | | | | | |
| Nonvascular[7] | N | | | | N | | | N | N | | |
N = new indication; P = previously cleared by FDA
(1) Abdominal includes Gynecology, Renal and Urology: Notes:
[2] Small Orgon includes breast, testes, and thyroid:
(3) Peripheral Vascular includes arteries and veins;
(4) Musculo-skeletol Conventional includes long bone, hip ond knee joint visualization:
[5] Tharacic/Pleural is pleural motion/sliding os well as fluid detection:
(6) Voscular Access includes intravenous, intro-arterial, central and peripheral lines;
(7) Nonvascular is image guidonce for freehand needle/catheter placement:
[*] Combined mode is B/Color.
(PLEASE DO NUT WRITE BELLOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health {OIR} Prescription Use (Per 21 CFR 801.109)
Section 4-6
11
Image /page/11/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The letters are stylized and have a vintage appearance. The overall design is simple yet recognizable, representing the brand identity of General Electric.
Diagnostic Ultrasound Indications for Use Form Vscan with Dual Probe with shallow scanning transducer (G8L)
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 | Doppler Modes | Color | |||||||
| M | Power | Combined | ||||||||
| Modes | Harmonic | |||||||||
| Imaging | Coded | |||||||||
| Pulse | Other | |||||||||
| Fetal/OB | ||||||||||
| Abdominal[1] | ||||||||||
| Pediatric | N | N | N | |||||||
| Small Organ[2] | N | N | N | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Peripheral Vascular[3] | N | N | N | |||||||
| Musculo-skeletal Conventional[4, 4] | N | N | N | |||||||
| Musculo-skeletal Superficial[5] | ||||||||||
| Thoracic/Pleural[6] | N | N | N | |||||||
| Exam Type, Means of Access | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Laparoscopic | ||||||||||
| Interventional Guidance | ||||||||||
| Vascular Access[7] | N | N | N | |||||||
| Nonvascular[8] | N | N | N |
N = new indication, P = previously cleared by FDA
(1) Abdominal includes Gynecology, Renal and Urology: Notes:
(2) Small Organ includes breast, testes, and thyroid;
[3] Peripheral Vascular includes arteries and veins:
[4] Musculo-skeletal Conventional includes long bone, hip and knee joint visualization;
(5) Thoracic/Pleural is pleural motion/sliding as well as fluid detection:
(6) Vascular Access includes intravenous, intra-arterial, central and peripheral lines;
(7) Nonvascular is image guidance for freehand needle/catheter placement;
[*] Combined mode is B/Color.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510{k) Number
Section 4-7