Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)

Device Description

The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.

AI/ML Overview

This document is a 510(k) Premarket Notification from Portavision Medical LLC for their MobileRay Pulse SE Digital Imaging System, demonstrating its substantial equivalence to a predicate device. The information provided heavily focuses on describing the device, comparing its technical specifications to a predicate, and detailing non-clinical bench testing for safety and effectiveness.

Crucially, the document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification." This means that the device's acceptance criteria and the proof of meeting them are not based on human reader studies, ground truth establishment, or clinical performance metrics discussed in an MRMC or standalone study. Instead, the acceptance criteria are met through demonstrating equivalence in technical specifications and successful completion of robust non-clinical bench testing.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding an AI component, MRMC study, ground truth, and expert adjudication, is not applicable to this specific 510(k) submission. This submission is for a conventional X-ray and fluoroscopy system, not an AI-powered diagnostic device.

However, I can extract information related to the device's performance based on the technical comparison and bench testing described. It's important to frame this within the context of technical equivalence rather than AI-driven performance metrics.

Acceptance Criteria and Device Performance (Based on Technical Equivalence and Bench Testing):

Since no clinical or AI-specific performance study was conducted or presented, the "acceptance criteria" here refer to the demonstration of technical equivalence and adherence to safety and performance standards for an X-ray imaging system. The "reported device performance" is a comparison of its technical specifications and safety/EMC test results against established predicate device characteristics and regulatory standards.

Acceptance Criterion (Demonstrated by Technical Equivalence / Bench Testing)	Reported Device Performance (MobileRay Pulse SE)
Indications for Use Equivalence	Intended for use by qualified/trained medical professionals for radiographic, multi-radiographic, and fluoroscopic imaging during diagnostic, surgery, and interventional procedures in healthcare facilities (skull, spinal column, chest, abdomen, extremities). Applicable to all patients except pediatrics, within device limits, performed sitting, standing, prone, or supine. Not for mammography. هذا يتوافق مع الاستخدامات المماثلة للجهاز السائد.
Generator Type Equivalence	High frequency Inverter type (Same as predicate).
Radiography KV range Equivalence	40 – 125 KV (Same as predicate).
Radiography mA range Equivalence	20 – 100 mA (Same as predicate).
Radiography mAs range Equivalence	0.8 – 200 mAs (Same as predicate).
Indicator Equivalence	Display on workstation monitor (Same as predicate).
Collimator Equivalence	Multi-leaf adjustable motorized (Same as predicate).
DICOM Compatibility Equivalence	Yes (Same as predicate).
Software Functionality Equivalence	Acquiring image, viewing, changing window/level, inverting, lookup table, zoom, pan, noise reduction, patient information, annotation, image rotation, X-ray generator control, DICOM worklist and Send (All same as predicate).
Electrical Safety & EMC Compliance	Compliant with EN 60601-1-2 (2015), EN 301 489-1 V2.2.0 (2017), EN 301 489-17 V3.2.0 (2017), IEC 60601-1: 2005 + Corr.1: 2006 + A1: 2012, EN 60601-1: 2006 + A11: 2011 + A1: 2013 + AC:2014 + A12:2014, UNE-EN 60601-1: 2008 + Corr.: 2010 + A11: 2010 + A11: 2012 + AC:2014 + A12:2015. Confirmed by bench testing. Also, digital panels' EMC and Electrical Safety previously submitted (K161942, K161966).
Software Validation Adherence	Validated according to FDA Software Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005."
Cybersecurity Adherence	Addressed in accordance with: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014)."
X-ray Source & Detector Alignment Safety Compliance	Incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). Includes a radiation inhibit safety circuit to prevent or immediately shut down radiation emission if alignment is lost within predetermined tolerances.
Automatic X-ray Beam Limiting Device Compliance	Incorporates an automatic X-ray beam limiting device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii).
X-ray Generator Thermal Stability (for Fluoroscopy)	Modified the cleared generator (K121410) with cooling fans to allow for repetitive exposures (fluoro/pulsed mode). Internal temperature rise measured during operation found to be acceptable.

Regarding the specific questions about an AI study (which are NOT applicable to this submission):

Sample size for the test set and data provenance: No test set of clinical images used for performance evaluation (AI or human reader) was mentioned. The "test set" in this context would be the device itself undergoing bench testing.
Number of experts used to establish ground truth & qualifications: Not applicable. No clinical ground truth was established for performance evaluation.
Adjudication method for the test set: Not applicable. No clinical test set to adjudicate.
MRMC comparative effectiveness study: Not applicable. No MRMC study was done, as this is a traditional imaging device, not an AI-assisted one. The document explicitly states "No clinical data is necessary."
Standalone performance: Not applicable in the context of AI. The device's "standalone" performance is its technical capability to produce X-ray images, which was assessed through bench testing and comparison to predicate technical specifications.
Type of ground truth used: Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used for performance evaluation.
Sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The "study" described in this 510(k) submission is a non-clinical bench testing and technical comparison study.

Objective: To demonstrate the substantial equivalence of the MobileRay Pulse SE Digital Imaging System to a legally marketed predicate device (EcoTron AnyView 500R Fluoroscopic Mobile X-ray System, K160279) and compliance with relevant safety and performance standards.
Methodology:
- Technical Comparison: Direct comparison of features, specifications (e.g., KV/mA ranges, generator type, software functions), and indications for use between the proposed device and the predicate.
- Bench Testing: Electrical safety and Electromagnetic Compatibility (EMC) testing according to international standards (e.g., EN 60601-1-2, IEC 60601-1). Thermal stability testing for the X-ray generator to ensure safe operation during fluoroscopy. Validation of software according to FDA guidance. Cybersecurity assessment.
Data Provenance: The data primarily comes from internal company testing and accredited lab testing for standard compliance. This is "prospective" bench testing data rather than retrospective or prospective clinical data. The country of origin for the data generation would be where the manufacturer and testing labs are located (not specified, but implied to be within typical regulatory testing frameworks).
Conclusion: The submission concludes that the MobileRay Pulse SE is as safe and effective as the predicate device due to similar indications for use, similar technological characteristics, and successful non-clinical bench testing demonstrating compliance with safety and performance standards. The key difference is the use of digital panels versus an image intensifier, and a unique source-to-image receptor alignment technology, but these are deemed "insignificant technological differences" that do not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Portavision Medical LLC % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES, FL 34114

Re: K191503

Trade/Device Name: MobileRay Pulse SE Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: Mav 29, 2019 Received: June 6, 2019

Dear Daniel Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel M. Burk, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191503

Device Name MobileRay Pulse SE Digital Imaging System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary, K191503

Image /page/3/Picture/1 description: The image shows the logo for PortaVision Medical. The logo consists of three blue circles with the letters P, V, and M in white. Below the circles, the words "PortaVision Medical" are written in a simple, sans-serif font.

PortaVision Medical LLC 800 Central Avenue Jefferson, Louisiana 70121 Phone: 866-783-4133 email: info@pvmed.net www.portavisionmedical.com Contact: Terry Ancar, Predsident Date Prepared: August 3, 2019

1. Identification of the Device:

Trade/Device Names: MobileRay Pulse SE Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System

2. Equivalent legally marketed device: K160279

Trade/Device Name: AnyView 500R Fluoroscopic Mobile X-ray System Manufacturer: EcoTron Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System

1. Reference Devices: (Used with this device, customer picks one of the units below. They differ only in size)

K161942

Trade/Device Name: XRpad2 3025 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB K161966 Trade/Device Name: XRpad2 4336 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB

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1. Indications for Use Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides radiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, and extremities. The device may be used for other imaging applications on all patients except pediatrics within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
1. Description of the Device: The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the

X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.

1. Safety and Effectiveness, comparison to predicate device. This device has similar indications for use and similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels. The chief differences are: The predicate uses a fixed Source to Image distance dictated by a "C-Arm," and uses image intensifier technology whereas the proposed new device uses a unique source to image receptor location technology and the image receptor is a digital panel. Otherwise the two systems have the same functionality and uses.

7. Substantial Equivalence Chart: (Next Page)

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Characteristic	EcoTron Anyview 500R K160279	MobileRay Pulse SE Digital ImagingSystem
Indications forUse:	Anyview-500R mobile C arm, fluoroscopic x-ray system, is radiation medical equipmentonly used by professional radiologists. Thisproduct is designed to provide fluoroscopicand spot film images of the patient duringdiagnostic and interventional procedures.This system can be applied in emergencyroom, operation room, cast room or etc. ofhospital	Intended for use by a qualified/trainedmedical professionals, who have fullunderstanding of the safety information andemergency procedures as well of capabilitiesand function of the device. The deviceprovides radiographic, multiradiographic andfluoroscopic imaging and is used for guidanceand visualization during diagnosticradiographic, surgery, and interventionalprocedures. The device is to be used inhealthcare facilities both inside and outsideof hospital, in a variety of procedures of theskull, spinal column, chest, abdomen, andextremities. The device may be used forother imaging applications on all patientsexcept pediatrics within the limits of thedevice. Applications can be performed withthe patient sitting, standing, or lying in theprone or supine position. The system is notintended for mammography applications
Energy Source	220V-230V, Single 50-60 Hz	110V-120V, Single 50-60Hz (4 kW) or220-230V Single 50-60Hz (8 kW)
SystemWeight andSize	200 lbs.35.75" x 28" x 72.5"	136 lbs.65" x 26" x 87"
GeneratorType	High frequency Inverter type	High frequency Inverter type
Output Power	5KW	4 kW (120v) or 8KW (220v)
Fluoroscopy
Pulse	0.5 – 20 mA	0.5 – 16mA
Boost	0.5 - 30 mA	N/A
Radiography
KV range	40 – 125 KV	40 – 125 KV
mA range	20 – 100 mA	20 - 100 mA
mAs range	0.8 – 200 mAs	0.8 – 200mAs
Pulse width	N/A	10 ms
Pulse rate	8, 15, 30	1 - 7.5 fps but see key advantageimmediately below:
Weight	552 lbs (Fairly heavy)	139 lbs. Much lighter and easier tomaneuver.
X-ray Tube	Rotating anode	Stationary anode
Characteristic	EcoTron Anyview 500R K160279	MobileRay Pulse SE Digital ImagingSystem
Indicators	Display on workstation monitor	Same as predicate
Collimator	Multi-leaf adjustable motorized	Multi-leaf adjustable motorized
Digital PanelSpecification	N/A, not digital	XRpad2 3025 100 μ, 3004 x 2508 pixelsXRpad2 4336 100 μ, 4288 x 3524 pixels
Pixel Pitch	N/A not digital	100 μ
Pixel Matrix	N/A not digital	3004 x 2508 or 4288 x 3524
ADConversion	N/A not digital	16 bits
DQE	N/A	75% (@ 0 lp/mm)
MTF	N/A	70% (1 lp/mm)
Imageacquisition	Image Intensifier 9/6/4.5 inE5830SD-P4A (TOSHIBA)	Amorphous Silicon Direct depositionCsl:TI
Connection	Ethernet or Wi-Fi	Same as predicate
DICOM	Yes	Same as predicate
ElectricalSafety	IEC60601-1:2005 + A1 (2012)IEC60601-1-2:2007	Same as predicate, See bench testinformation below.
Photo	Image: EcoTron Anyview 500R K160279	Image: MobileRay Pulse SE Digital Imaging System

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The following table compares The MobileRay Pulse SE software to the predicate software.

Feature	Predicate DeviceEcoTron Anyview K160279	Proposed DeviceMobileRay Pulse SE
Acquiring image from detector	Yes	Yes
Viewing image	Yes	Yes
Change window/level	Yes	Yes
Invert	Yes	Yes
Lookup Table	Yes	Yes
Zoom	Yes	Yes

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Feature	Predicate DeviceEcoTron Anyview K160279	Proposed DeviceMobileRay Pulse SE
Pan	Yes	Yes
Noise Reduction	Yes	Yes
Patient Information	Yes	Yes
Annotation	Yes	Yes
Image rotation	Yes	Yes
X-Ray generator control	Yes	Yes
DICOM worklist and Send	Yes	Yes

1. Summary of non-clinical testing: Bench testing was performed to assess the device safety and effectiveness. Electrical safety and EMC testing was performed on the unit. The standards employed were: EN 60601-1-2 (2015): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests EN 301 489-1 V2.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements & EN 301 489-17 V3.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems AND: IEC 60601-1: 2005 + Corr.1: 2006 + A1: 2012 EN 60601-1: 2006 + A11: 2011 + A1: 2013 + AC:2014 + A12:2014 UNE-EN 60601-1: 2008 + Corr.: 2010 + A11: 2010 + A11: 2012 + AC:2014 + A12:2015 POSE000 14 (General procedure of Safety Lab) EMC and Electrical Safety performance for the digital receptor panels had previously been submitted to FDA in K161942 and in K161966. Software has been written and validated according to the FDA Software Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 Cybersecurity concerns have been addressed in accordance with: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014). In order to be able to perform fluoroscopic exposures the x-ray generator (cleared in K121410) was modified to include cooling fans and to allow for repetitive exposures, i.e. fluoro/pulsed mode. The internal temperature rise in the generator was measured during operation and found to be acceptable.
1. Summary of clinical testing: No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. The digital panels both received previous 510(k) clearances
1. Conclusion: After analyzing software integration validation, safety testing data, and bench test images, it is the conclusion of PortaVision Medical LLC that the MobileRay Pulse SE Digital Imaging System is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.