Vscan Extend
Device Facts
| Record ID | K161588 |
|---|---|
| Device Name | Vscan Extend |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
| Product Code | IYN · Radiology |
| Decision Date | Aug 31, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Vscan Extend is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's 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, and triage.
Device Story
Vscan Extend is a pocket-sized, battery-powered diagnostic ultrasound system; consists of handheld unit with 5-inch touchscreen and permanently attached probe (sector phased array or dual-headed phased/linear array). Device performs digital acquisition, processing, and display of ultrasound images. Used by trained healthcare professionals in clinical settings for basic focused assessments, triage, and procedure guidance (e.g., needle/catheter placement). Supports wireless image transfer to DICOM servers/Windows shares; data export via USB. Includes access to GE Marketplace for software application downloads. Provides clinicians with real-time visualization of anatomical structures and fluid to assist in clinical diagnosis and monitoring. Benefits include portability and integration into routine examinations.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing in accordance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/3, and ISO 10993-1.
Technological Characteristics
Pocket-sized, battery-powered ultrasound system. Transducers: phased array (deep) and linear array (shallow). Connectivity: WiFi, DICOM, USB. Software: supports downloadable applications via GE Marketplace. Safety standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/3, ISO 10993-1, ISO 14971. Biocompatible materials. Internal storage encryption for data privacy.
Indications for Use
Indicated for qualified healthcare professionals for diagnostic ultrasound imaging, measurement, and analysis of anatomical structures and fluid. Applications include: Cardiac, Abdominal, Renal, OB/GYN, Urology, Fetal, needle/catheter guidance, peripheral vascular (arteries/veins), thoracic/lung, adult cephalic, pediatric, small organs (thyroid), and musculoskeletal (long bone, hip, shoulder, elbow, knee).
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
- Vscan with Dual Probe (K140693)
Reference Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K161588 Trade/Device Name: Vscan Extend Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 10, 2016 Received: August 11, 2016
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 does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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.
August 31, 2016
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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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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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)
K161588 Device Name Vscan Extend
Indications for Use (Describe)
V scan Extend is a general purpose diagnostic ultrasing system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's 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 dagnosis purposes during routine, periodic monitoring, and triage.
With the plased array transducer on the specific clinical applications and exam types include: Cardia: Abdominal: Renal: OB/GYN; Urology: Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle Catheter Placement (e.g. paracentesis, pericardiocentesis, anniocentesis): Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.
With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular inaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Snall Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip. shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediativs.
Type of Use (Select one or both, as applicable) X 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)
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#### Diagnostic Ultrasound Indications for Use Form Vscan Extend Ultrasound System
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|----|----|-------|---------|-------|-------------------|---------------------|----------------|-------|
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Fetal/OB | N | | | | N | | | N | N | | 7 |
| Abdominal[1] | N | | | | N | | | N | N | | 7 |
| Pediatric | N | | | | N | | | N | N | | 7 |
| Small Organ[2] | N | | | | N | | | N | | | 7 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | | | | N | | | N | N | | |
| Cardiac Adult | N | | | | N | | | N | N | | 7 |
| Cardiac Pediatric | N | | | | N | | | N | N | | 7 |
| Peripheral Vascular[3] | N | | | | N | | | N | N | | 7 |
| Musculo-skeletal Conventional[4] | N | | | | N | | | N | | | 7 |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | N | | | | N | | | N | N | | 7 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access[6] | N | | | | N | | | N | | | 7 |
| Nonvascular | N | | | | N | | | N | N | | 7 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA in K140693
Notes:
[1] Abdominal includes Gynecology, Renal and Urology;
[2] Small Organ includes thyroid;
[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;
[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;
[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined mode is B/Color.
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### Diagnostic Ultrasound Indications for Use Form Vscan Extend with deep scanning-phased array transducer (G3S)
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|----|----|---------------|------------|-------|-------------------|---------------------|----------------|-------|
| | B | M | PW | CW | Doppler Modes | Color<br>M | Power | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Fetal/OB | P | | | | P | | | P | P | | 7 |
| Abdominal[1] | P | | | | P | | | P | P | | 7 |
| Pediatric | P | | | | P | | | P | P | | 7 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | | | | N | | | N | N | | |
| Cardiac Adult | P | | | | P | | | P | P | | 7 |
| Cardiac Pediatric | P | | | | P | | | P | P | | 7 |
| Peripheral Vascular[3] | P | | | | P | | | P | P | | 7 |
| Musculo-skeletal Conventional[4] | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | P | | | | P | | | P | P | | 7 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Vascular Access[6] | | | | | | | | | | | |
| Nonvascular | P | | | | P | | | P | P | | 7 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA in K140693
Notes:
[1] Abdominal includes Gynecology, Renal and Urology;
[2] Small Organ includes thyroid;
[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;
[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;
[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] Image guidance for freehand needle/catheter placement;
[*] Combined mode is B/Color.
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR) Prescription Use (Per 21 CFR 801.109)
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# Diagnostic Ultrasound Indications for Use Form Vscan Extend with shallow scanning-linear array transducer (G8L)
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|---|----|----|---------------|------------|-------|-------|---------|-------------------------|-------|--|--|
| | | | | | Doppler Modes | | | | | Combined Harmonic Coded | | | |
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color<br>M | Power | Modes | Imaging | Pulse | Other | | |
| Fetal/OB | | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | | |
| Pediatric | P | | | | P | | | P | | | 7 | | |
| Small Organ[2] | P | | | | P | | | P | | | 7 | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Peripheral Vascular[3] | P | | | | P | | | P | | | 7 | | |
| Musculo-skeletal Conventional[4] | P | | | | P | | | P | | | 7 | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | | |
| Thoracic/Pleural[5] | P | | | | P | | | P | | | 7 | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | | |
| Vascular Access[6] | P | | | | P | | | P | | | 7 | | |
| Nonvascular[7] | | | | | | | | | | | | | |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA in K140693
Notes:
[1] Abdominal includes Gynecology, Renal and Urology;
[2] Small Organ includes thyroid;
[3] Peripheral Vascular includes arteries and veins, lower extremity, carotid;
[4] Musculo-skeletal Conventional includes long bone, hip, shoulder, elbow and knee joint visualization;
[5] Thoracic/Pleural is pleural motion/sliding, line artifacts as well as fluid detection;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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 (OlR) Prescription Use (Per 21 CFR 801.109)
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## 510(k) Summary
| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date:<br>Submitter: | June 7, 2016<br>GE Medical Systems Ultrasound and Primary Care Diagnostics,<br>LLC<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262) 676-6120<br>F:(414) 918-8275 |
| Secondary Contact Person: | Sadashiva Subraya<br>Regulatory Affairs Leader<br>GE Healthcare<br>T: +91 80 4088 2969 |
| Device:<br>Trade Name: | Vscan Extend |
| Common/Usual Name: | Ultrasound system |
| Classification Names:<br>Product Code: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary Predicate<br>Device(s): | Vscan with Dual Probe - K140693 |
| Reference Predicate<br>Device(s): | Venue 50 - K152758<br>Venue 40 - K112122 |
| Device Description: | Vscan Extend is a pocket-sized, battery powered general purpose,<br>track 3, diagnostic ultrasound system. The system consists of a<br>handheld unit with a 5 inch touch screen display and a<br>permanently attached probe. The probe is available in one of two<br>configurations: a sector probe with phased array transducer or<br>both phased and linear array transducers in the single probe (dual<br>probe). It has digital acquisition, processing and display<br>capabilities. The device specific battery can be charged either in<br>the system or independently. The system also may include an<br>AC/DC adapter with cable, case, Micro SD card, USB cable, or<br>other accessories. |
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The system is capable of transferring images wirelessly to a DICOM server or Windows share. Data can also be exported to the user's computer by using the USB export option and a standard USB/micro USB cable. Capabilities also include access to GE Marketplace. which shall allow the user to download software applications to the device.
Vscan Extend is a general purpose diagnostic ultrasound imaging Intended Use: system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's 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, and triage.
> With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.
> With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics.
- Technology: The Vscan Extend employs the same fundamental scientific technology as its predicate devices.
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#### Determination of Comparison to Predicates Substantial Equivalence:
The Vscan Extend is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound ● imaging and fluid flow analysis.
- The proposed Vscan Extend and predicate Vscan with ● Dual Probe have the same clinical intended use and clinical applications except that addition of adult cephalic that was cleared on the Venue 40 predicate.
- . The proposed Vscan Extend and predicate Vscan with Dual Probe have the same imaging modes.
- . The proposed Vscan Extend and predicate Vscan with Dual Probe are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The proposed Vscan Extend and predicate device Vscan ● with Dual Probe have the same phased array transducer for deep scanning and linear array transducer for shallow scanning.
- The proposed Vscan Extend and predicate Vscan with Dual Probe have similar acoustic power levels. All values are below FDA applicable limits.
- . The proposed Vscan Extend and predicate Vscan with Dual Probe have the same capability in terms of performing measurements, capturing digital images and reviewing the images.
- . The proposed Vscan Extend has WiFi connectivity similar to the predicate device Venue 50.
- The proposed Vscan Extend and predicate device Venue ● 50 system have same data privacy features including internal storage encryption which allows the user to encrypt patient data.
- The proposed Vscan Extend has DICOM connectivity similar to the predicate device Venue 50.
- The proposed Vscan Extend and predicate systems have ● been designed in compliance with approved electrical and physical safety standards.
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like shapes, also in blue, which give the logo a dynamic and recognizable appearance.
## Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Vscan Extend and its applications comply with voluntary standards:
- . AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance, 2005
- IEC60601-1-2,Medical Electrical Equipment Part 1-. 2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
- IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- NEMA UD 3, Standard for Real Time Display of . Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
- ISO10993-1, Biological Evaluation of Medical ● Devices- Part 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2. Acoustic Output Measurement Standard . for Diagnostic Ultrasound Equipment, 2004
- ISO14971, Application of risk management to medical ● devices: Second edition, 2007
- NEMA PS 3.1 3.20 (2011), 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)
- Performance testing (Verification) ●
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- . Safety testing (Verification)
- . Verification of Privacy & Security Design
Transducer materials are biocompatible.
## Summary of Clinical Tests:
The subject of this premarket submission, Vscan Extend, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the Vscan Extend to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
