This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)

Device Description

This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is required. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators.

AI/ML Overview

The provided document is a 510(k) summary for the Fusion Digital Diagnostic X-Ray Upgrade Kit (K141743). It explicitly states that "No new testing was done because no modifications have been made other than deleting the generator and tube stand" for both non-clinical and clinical tests (Sections 7 and 8 on page 4).

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the K141743 submission.

The document refers to a previous clearance (K132294) for the "IDENTICAL digital x-ray panel/software/workstation." To obtain the requested information, one would need to review the 510(k) submission for K132294.

Based on the provided document K141743, the following questions cannot be answered:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

RADIOLOGY SOLUTIONS LLC % Daniel Kamm, P.E. Principal Engineer Kamm & Associate 8870 Ravello Court NAPLES FL 34114

Re: K141743

Trade/Device Name: Fusion Digital Diagnostic X-ray Upgrade Kit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 1, 2014 Received: September 4, 2014

Dear Mr. 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. 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.

{1}------------------------------------------------

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.

Smhff)

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) K141743

Device Name FUSION DIGITAL X-RAY DETECTOR (upgrade kit)

Indications for Use (Describe)

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)

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 Druq 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."

{3}------------------------------------------------

510(k) Summary - K141743

1. Submitter: RADIOLOGY SOLUTIONS LLC 1912 Golfcrest Dr Commerce Twp, MI 48382 Tel. 866.681.6681 Date Prepared: September 19, 2014 Contact: Scott Milgrom, President
1. Identification of the Device: Fusion Digital Diagnostic X-Ray Upgrade Kit. Classification Name: Stationary X-ray system Common/Usual Name: Digital X-ray Panel (upgrade kit) Regulation Numbers: 21 CFR 892.1680; Product Code: MQB
1. Predicate Device: Fusion Digital Diagnostic X-Ray Upgrade Kit uses the IDENTICAL digital x-ray panel/software/workstation that was cleared in K132294. The only difference is the generator and tubestand is not supplied.
1. A description of the device: This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is reguired. Problems which ensue when system is depended upon for timing...the most crucial part in the digital Image creation... are eliminated. These are the vast majority of service issues in DR retrofits. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators. Testing has not been conducted regarding compatibility with other generators.
ഗ് Intended use of the device: This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
1. The Galaxy and Galaxy Plus have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device Sedecal. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands are from different manufacturers but with functionally identical capabilities.

{4}------------------------------------------------

Comparison Table

Characteristic	Galaxy and Galaxy+ Plus K132294	Fusion Digital Diagnostic X-Ray Upgrade Kit.
Indications	Intended for use by a qualified/trained doctoror technician on subjects for taking diagnosticradiographic exposures of the skull, spinalcolumn, chest, abdomen, extremities, and otherbody parts. Applications can be performed withthe patient sitting, standing, or lying in theprone or supine position. (Not formammography)	This flat panel digital imaging system isintended for use in generating radiographicimages of human anatomy. This device isintended to replace film/screen systems in allgeneral purpose diagnostic procedures. Thisdevice is intended for use by qualified medicalpersonnel. (Not for mammography)
Digital ReceptorPanel	Atlaim ATAL 8 AND ATAL 8C (Cleared inK113812) to be known as "IRIS" AND "IRIS C"	SAME
PanelCommunication	Tethered Ethernet, one panel	SAME
PanelResolution	Pixel size 139 x 139 μmImage matrix size 3072 x 3072 pixelsNumber of pixels Approx. 9.4 million pixels	SAME
DICOM	Yes (Same software as cleared in K112527) tobe known as "Nexxus"	SAME
Tube Stand	Same	NOT SUPPLIED
Generator	CPI, 40-50-65-or 80 kW (High Frequency)	NOT SUPPLIED but compatible with CPI CMP200 and Sedecal SHF series generators.
Safety	UL/CSA Listings and IEC Standards IEC 60601-1and IEC 60601-1-2, US Performance Standards	SAME
Photo	Image: Galaxy+ Plus	Image: Digital Receptor Panel

Description of non-clinical tests. No new testing was done because no modifications have been 7. made other than deleting the generator and tube stand.
1. Description of clinical tests. No new testing was done because no modifications have been made other than deleting the generator and tube stand.
1. Conclusions drawn: The nonclinical tests performed in our previous clearance demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device that was our original predicate. Installation of the upgrade kit must be done by a qualified service technician and performance should be verified by the facility radiation physicist.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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 radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.