(58 days)
No
The description focuses on passive magnetic tracking and software interpretation of sensor data, not AI/ML algorithms for image analysis or decision support.
No.
The device provides ultrasound guidance and visual tools for needle placement, but it does not directly treat or diagnose a disease or condition. Its purpose is to assist clinicians during procedures.
No
The device is primarily used for guiding the placement of needles and catheters in vascular structures and for imaging various organs and structures of the body. While imaging can be part of a diagnostic process, the primary intended use described here is for interventional guidance and general imaging, not for making a diagnosis.
No
The device description explicitly states that the technology consists of "software installed on an ultrasound system and sensors incorporated into the ultrasound probe," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides ultrasound guidance for placement of needles and catheters in vascular structures and performs ultrasound imaging of various body structures. This is a diagnostic imaging and procedural guidance device used on the patient, not a device used to examine specimens from the patient.
- Device Description: The description reinforces that it's an ultrasound system designed to assist physicians in gaining vascular access and tracking needles in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on the analysis of such samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (inside the body) through ultrasound imaging and needle tracking.
N/A
Intended Use / Indications for Use
The Site® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The SiteRite® 6 Ultrasound System is a portable, B-mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the Site~Rite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.
The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Vascular structures, various organs and structures of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in hospital settings (intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories).
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)
Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements. The following standards in conjunction with internal protocols were used to determine appropriate methods for evaluating the performance of the subject device:
IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.1
IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
IEC 60601-2-37:2007 Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 60601-1-6:2010 Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability
IEC 62304:2006 Medical Device Software - Software Life Cycle Processes – Edition 1.0
IEC 62366:2007 Medical Devices - Application of Usability Engineering to Medical Devices – Edition 1.0
ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device. Where differences between the subject and primary predicate device exist with respect to technological characteristics, consideration to the reference devices was given to support those technological characteristics.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
C.R. Bard, Inc. Bard Access Systems. Inc. % Ms. Kerrie Hamblin Regulatory Affairs Project Manager 605 North 5600 West SALT LAKE CITY UT 84116
Re: K142443
Trade/Device Name: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: August 29, 2014 Received: September 2, 2014
Dear Ms. Hamblin:
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.
This determination of substantial equivalence applies to the following transducers intended for use with the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, as described in your premarket notification:
Transducer Model Number
Pinpoint™ GT 20 mm 64 Element Linear Probe
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm. 77)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology
Indications for Use (Describe)
The Site® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
| 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)
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3
Diagnostic Ultrasound Indication for Use
Ultrasound System: Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology (Ultrasound without transducer)
| Clinical
Applications | A | B | M | PWD | CWD | Mode of Operation | | | Combined
(specify) | Other
(specify) |
|-------------------------------------------------------------------------|---|---|---|-----|-----|-------------------|----------------------|---------------------------|-----------------------|--------------------|
| | | | | | | Color
Doppler | Amplitude
Doppler | Color Velocity
Imaging | | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative
(epiaortic scanning) | | P | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(breast, testes, thyroid, etc.) | | P | | | | | | | | |
| Neonatal
Cephalic | | P | | | | | | | | N [1] |
| Adult Cephalic | | P | | | | | | | | N [1] |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transeurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral
Vascular | | P | | | | | | | | N [1] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| Notes: [1] Needle Guidance Imaging | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
(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 K142443
Prescription Use (per 21 CFR 801.109
4
Diagnostic Ultrasound Indication for Use
Ultrasound System: Site~Rite 6 Ultrasound System with Pinpoint™ GT Technology Transducer: Pinpoint™ GT 20 mm 64 Element Linear Probe
| Clinical Applications | A | B | M | PWD | CWD | Mode of Operation | | | | Other
(specify) |
|-------------------------------------------------------------------------|---|---|---|-----|-----|-------------------|-------------------|------------------------|-----------------------|--------------------|
| | | | | | | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined
(specify) | |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | |
| Intraoperative
(epiaortic
scanning) | | P | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(breast, testes,
thyroid, etc.) | | P | | | | | | | | |
| Neonatal
Cephalic | | P | | | | | | | | N [1] |
| Adult Cephalic | | P | | | | | | | | N [1] |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transeurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral
Vascular | | P | | | | | | | | N [1] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | P | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Notes: [1] Needle Guidance Imaging (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 K142443
Prescription Use (per 21 CFR 801.109
5
510(k) Summary
21 CFR 807.92
| General Provisions: | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Kerrie Hamblin | |
| Regulatory Affairs Project Manager | ||
| Bard Access Systems, Inc. | ||
| Kerrie.Hamblin@crbard.com | ||
| 801-522-5000 ext. 4909 | ||
| 801-522-5425 fax | ||
| Date of Preparation: | 29 August 2014 | |
| Subject Devices: | Trade Names: | Site-Rite® 6 Ultrasound System with Pinpoint™ GT |
| Technology | ||
| Classification | ||
| Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging | |
| System | ||
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo, | |
| Ultrasonic | ||
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | ||
| Primary | ||
| Predicate | ||
| Device: | Trade Name: | Site-Rite® 6 Ultrasound System |
| Classification | ||
| Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging | |
| System | ||
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo, | |
| Ultrasonic | ||
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | ||
| Premarket | ||
| Notification: | K071204, concurrence, 18 May 2007 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Reference | ||
| Devices: | Trade Name: | Site-Rite Vision® II Ultrasound System |
| Classification | ||
| Name: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler Imaging | |
| System | ||
| IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging | ||
| System | ||
| LLZ, 21 CFR 892.2050, Picture Archiving and | ||
| Communications System | ||
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler, | |
| Ultrasonic | ||
| IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo, | ||
| Ultrasonic | ||
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | ||
| LLZ, 21 CFR 892.2050, System, Image Processing, | ||
| Radiological | ||
| Premarket | ||
| Notification: | K132942, concurrence, 17 October 2013 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Trade Name: | GE LOGIQ E9 | |
| Classification | ||
| Name: | IYN, CFR 892.1550, Ultrasonic Pulsed Doppler Imaging | |
| System | ||
| IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging | ||
| System | ||
| ITX, 21 CFR 892.1570, Diagnostic Ultrasonic Transducer | ||
| Common Name: | IYN, CFR 892.1550, System, Imaging, Pulsed Doppler, | |
| Ultrasonic | ||
| IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo, | ||
| Ultrasonic | ||
| ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic | ||
| Premarket | ||
| Notification: | K092271, concurrence, 17 November 2009 | |
| Manufacturer: | GE Healthcare | |
| Trade Name: | Electromagnetic Tracking System (VirtuTRAX) | |
| Classification | ||
| Name: | IYO, 21 CFR 892.1560, Ultrasonic Pulsed Echo Imaging | |
| System | ||
| JAK, 21 CFR 892.1750, Computed Tomography X-Ray | ||
| System | ||
| Common Name: | IYO, 21 CFR 892.1560, System, Imaging, Pulsed Echo, | |
| Ultrasonic | ||
| JAK, 21 CFR 892.1750, System, X-Ray, Tomography, | ||
| Computed | ||
| Premarket | ||
| Notification: | K092619, concurrence, 13 November 2009 | |
| Manufacturer: | CIVCO Medical | |
| Descriptions: | mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The Site |
The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process. | |
| Intended
Use/Indications for
Use: | The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data. | |
| Technological
Characteristics: | The SiteRite® 6 Ultrasound System with Pinpoint™ GT Technology employs the same fundamental scientific technology as the primary predicate device, SiteRite® 6 Ultrasound System (K071204), in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. The SiteRite® 6 Ultrasound System with Pinpoint™ GT Technology has also been evaluated with consideration to multiple reference devices where differences in technology between the subject and primary predicate device are present. The subject device is technologically similar to the reference devices, SiteRite Vision® II Ultrasound System (K132942), GE LOGIQ E9 (K092271), and Electromagnetic Tracking System – VirtuTRAX (K092619). | |
| Safety and
Performance Tests: | Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements. The following standards in conjunction with internal protocols were used to determine appropriate methods for evaluating the performance of the subject device:
IEC 60601-1:2005,
CORR. 1(2006),
CORR 2(2007) Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.1
IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | |
| | IEC 60601-2-
37:2007 | Medical Electrical Equipment - Part 2-37: Particular
Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and
Monitoring Equipment |
| | IEC 60601-1-6:2010 | Medical Electrical Equipment-Part 1-6: General
Requirements for Basic Safety and Essential Performance
– Collateral Standard: Usability |
| | IEC 62304:2006 | Medical Device Software - Software Life Cycle Processes
– Edition 1.0 |
| | IEC 62366:2007 | Medical Devices - Application of Usability Engineering to
Medical Devices – Edition 1.0 |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing Within a Risk Management
Process |
| | The subject device met all pre-determined acceptance criteria and demonstrated
substantial equivalence as compared to the primary predicate device. Where
differences between the subject and primary predicate device exist with respect
to technological characteristics, consideration to the reference devices was given
to support those technological characteristics. | |
| Summary of
Substantial
Equivalence | The subject device, SiteRite® 6 Ultrasound System with Pinpoint™ GTRite® 6 Ultrasound System (K071204). The subject device has similar
Technology, has the same intended use as the primary predicate device,
Site
indications for use, technological characteristics, and safety and performance
testing as the primary predicate device. Where there are differences in
indications for use and technological characteristics between the subject device
and the primary predicate device, consideration to the reference devices,
SiteRite Vision® II Ultrasound System (K132942), GE LOGIQ E9 UltrasoundRite® 6 Ultrasound System with Pinpoint™ GT
System (K092271), and Electromagnetic Tracking System – VirtuTRAX
(K092619) was given. The Site
Technology met the predetermined performance requirements for its intended
use and is as safe, as effective, and performs as well as or better than the
primary predicate device, SiteRite® 6 Ultrasound System (K071204). Based onRite® 6 Ultrasound System with Pinpoint™ GT
this assessment, the subject Site
Technology is determined to be substantially equivalent to the primary predicate
device, Site~Rite® 6 Ultrasound System. | |
Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology
6
7
8