The dicomPACS® DX-R with 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 not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Device Description

The dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable 3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimization of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called "console software" as it is installed on the so-called "console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with optimum workflow for their work. The key difference between the modified device and our predicate device is the panels are wireless, Wi-Fi.

AI/ML Overview

The provided text describes the dicomPACS DX-R with flat panel digital imaging system. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding device performance metrics. Instead, it relies on a qualitative assessment against predicate devices and standard performance measurements.

Acceptance Criteria Category	Reported Device Performance (Qualitative Description)
Image Quality (Clinical)	"The panels produce images that are clinically acceptable. The images are of excellent quality, high resolution and are comparable to or better than the images from the predicate devices."
Safety (Electrical & EMC)	"Electrical safety and EMC testing was conducted by the respective panel manufacturers in compliance with IEC 60601-1 and IEC 60601-1-2."
Software Validation & Risk	"Software validation and risk analysis was conducted in compliance with FDA guidance documents."
Technical Performance (Panel)	"MTF, DQE, linearity, and resolution measurements" performed by panel suppliers. (No specific values reported in this document.)
Wireless Coexistence	"Wireless coexistence is assured via use of standard 802.11(n)."
Substantial Equivalence	"The dicomPACS® DX-R with flat panel, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Images from all three panels were reviewed by a US Board Certified Radiologist." It does not specify the exact sample size (number of images or patients) used for this clinical review of the test set.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: One.
Qualifications: "US Board Certified Radiologist." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The review was conducted by a single radiologist.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not explicitly mentioned for comparing human readers with and without AI assistance. The study described focuses on the standalone performance of the imaging system and its equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study described is essentially a standalone performance evaluation of the dicomPACS DX-R system with flat panels. It assesses the basic imaging capabilities (image quality, technical metrics) of the device itself rather than its performance in conjunction with an AI algorithm for diagnosis. The "software" referred to in the description is "console software" for image acquisition, processing, and optimization, not an AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical image review was established by expert consensus (in this case, by a single US Board Certified Radiologist who determined clinical acceptability, resolution, and comparability to predicate devices). It's based on the radiologist's interpretation and judgment of the images.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device described is an imaging system and associated software, not an AI diagnostic algorithm that requires a separate training phase. The "software" mentioned (dicomPACS DX-R) handles image acquisition, processing, and optimization, not diagnostic interpretation based on learned patterns.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm is mentioned in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked vertically, creating a sense of unity and collaboration.

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

August 29, 2014

Oehm und Rehbein GmbH % Daniel Kamm, P.E. Principal Engineer ( Kamm & Associates) 8870 Ravello Ct NAPLES, FL 34114

Re: K141440

Trade/Device Name: dicomPACS DX-R with flat panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MOB Dated: May 29, 2014 Received: June 2, 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.

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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. O'Hara
for

Janine M Morris Division Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141440

Device Name dicomPACS DX-R with flat panel

Indications for Use (Describe)

The dicompacs dx-r with 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 not intended for mammography applications. This device is intended for use by qualified medical persomel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the patient.

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)

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Image /page/3/Picture/0 description: The image contains the logo for "OR Technology". The logo consists of a 2x2 grid of squares on the left, with the bottom left square being blue and containing a smiley face. The other three squares are gray. To the right of the squares is the text "OR Technology" in blue, followed by the text "| Digital X-ray and | Imaging Solutions" in a smaller font.

510(k) Summary K140551

SubmissionCorrespondent:	Oehm und Rehbein GmbHContact: Franziska GüntherPhone: (49) 381 36 600 500Email: franziska.guenther@or-technology.com
EstablishmentRegistration Number:	3006542593
Submission Sponsor:	Oehm und Rehbein GmbHNeptunallee 7c18057 RostockGERMANYPhone: (49) 381 36 600 500Fax: (49) 381 36 600 555
Date summary prepared:	May 23, 2014
Device trade name:	dicomPACS®DX-R with flat panel
Device common name:	Solid State X-ray Imager (Flat Panel/Digital Imager)
Classification:	Class II
Product codes:	MQB at 21 CFR Part 892.1680 LLZ at 21 CFR Part 892.2050
Predicate devices:	K131211, dicomPACS®DX-R; Oehm und Rehbein GmbH.
Description of thedevice:	The dicomPACS®DX-R with flat panel digital imaging system consists of twocomponents, the dicomPACS®DX-R software for viewing captured images ona Windows based computer, and one of three solid state X-ray imagingdevices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). Thesystem will display high quality images in less than five seconds over a widerange of X-ray dose settings. The software has the following characteristics:The dicomPACS® DX-R software runs on an off-the shelf PC which forms theoperator console. Images captured with the flat panel digital detector arecommunicated to the operator console via LAN or WLAN connection,depending on the model and the user's choice. dicomPACS®DX-R softwareuses the software API of the panel manufacturers to control the flat panels andto receive and to calibrate image data. The dicomPACS® DX-R software is anindependent product for the acquisition, processing and optimization of X-rayimages (raw images) provided by flat panel (DR) systems or CR systems. Ingeneral, such software is also called ",console software" as it is installed on theso-called ",console PC" of the imaging device. dicomPACS® DX-R carries outthe image processing of the raw images provided by the particular device andprovides the radiographer / X-ray assistant with optimum workflow for theirwork. The key difference between the modified device and our predicate deviceis the panels are wireless, Wi-Fi.
X-Ray GeneratorsSupported	ManufacturerSedecal, SpainStadler, SwizerlandRöntgenwerk Bochum, GermanyCPI, CanadaEMD TechnologiesControl-X, HungaryShimadzu, Japan	Product NameSHF and RST types8X SeriesEditor HFe401 - 801Indico100, CMP 200 DREPS 45-80

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Image /page/4/Picture/0 description: The image contains the logo for OR Technology. The logo consists of a 2x2 grid of rounded squares on the left, with the bottom left square being blue and containing a smiley face. To the right of the squares is the text "OR Technology" in a sans-serif font, followed by "| Digital X-ray and | Imaging Solutions" in a smaller font.

Indications for Use	The dicomPACS® DX-R with flat panel digital imaging system is intended foruse in generating radiographic images of human anatomy. This device isintended to replace film/screen systems in all general purpose diagnosticprocedures. This device is not intended for mammography applications.This device is intended for use by qualified medical personnel and iscontraindicated when, in the judgment of the physician, procedures would becontrary to the best interest of the patient.
Substantialequivalence topredicate devices:	All three receptor panels are identical in structure and share nearlyidentical Indications for Use. The included software offers the samefunctions as previously cleared in our software K131211. All panels sharesimilar technical parameters as well as the same materials and conversiontechnique. All panels have been previously cleared by FDA.The key technical difference is that the new panels are wireless, usingstandard Wi-Fi technology.
Summary ofTechnologicalCharacteristics	The three new panels have the following specifications;Thales Pixium Portable 2430 EZ (wireless) 24 x 30 cm, 148 $\mu$ m pixelsThales Pixium Portable 3543 EZ (wireless) 35 x 43 cm, 148 $\mu$ m pixelsPerkin Elmer 4336 XRpad (wireless) : 35 x 43 cm, 100 $\mu$ m pixelsAll use standard Wi-Fi communications and have wired Ethernet available.
Summary of Findingsfrom Non-ClinicalTesting	Electrical safety and EMC testing was conducted by the respective panelmanufacturers in compliance with IEC 60601-1 and IEC 60601-1-2.Software validation and risk analysis was conducted in compliance withFDA guidance documents. The suppliers of the respective panelsperformed MTF, DQE, linearity, and resolution measurements. Wirelesscoexistence is assured via use of standard 802.11(n). Wirelesscommunication technology was chosen with the FDA wireless guidancedocument taken into consideration.
Summary of Findingsfrom Review of ClinicalImages	Images from all three panels were reviewed by a US Board CertifiedRadiologist The panels produce images that are clinically acceptable. Theimages are of excellent quality, high resolution and are comparable to orbetter than the images from the predicate devices. A clinical study asdescribed in the FDA Guidance Document Guidance for the Submission of510(k)'s for Solid State X-ray Imaging Devices Document issued on: August6, 1999 was conducted successfully.
Conclusion:	There are no significant differences between the dicomPACS® DX-R with flatpanel digital imaging system and the predicate devices and therefore,dicomPACS® DX-R with flat panel does not raise any questions regardingsafety and effectiveness. The dicomPACS® DX-R with flat panel, asdesigned, is as safe and effective as the predicate devices, and the device isdetermined to be substantially equivalent to the referenced predicate devicescurrently on the market

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.