The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human antomy. 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 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: Toshiba FDX4343R, Toshiba FDX3543RP, or Konica Minolta AeroDR P-11 (1417HQ). 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 optimisation 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 an optimum workflow for their work.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "Images are clinically acceptable; quality, resolution comparable to or better than predicate devices.",
    "Reported Device Performance": "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."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The text only mentions \"Images from all three panels were reviewed\". A specific sample size for the test set is not provided. The data provenance is not explicitly stated, but the reviewer is a US Board Certified Radiologist, suggesting the evaluation was relevant to US clinical standards.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "One US Board Certified Radiologist was used to review the images and establish clinical acceptability.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "No specific adjudication method is described, as only one radiologist reviewed the images.",
  "5. 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": "No MRMC comparative effectiveness study was done. The study conducted was a review of images by a single radiologist to confirm clinical acceptability and comparability to predicate devices, as described in the FDA Guidance Document for Solid State X-ray Imaging Devices.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The study was not a standalone (algorithm only) performance study. It involved a human reviewer (radiologist) assessing the output of the device (images).",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Expert consensus by a single US Board Certified Radiologist on the clinical acceptability, quality, and resolution of the images.",
  "8. The sample size for the training set": "Not applicable. This device is a digital X-ray imaging system, not an AI/ML algorithm that requires a training set in the conventional sense. The performance evaluation focuses on the image quality produced by the system.",
  "9. How the ground truth for the training set was established": "Not applicable, as this is not an AI/ML device requiring a training set."
}

Summary

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KBI211

Image /page/0/Picture/1 description: The image contains the logo for "OR Technology". The logo consists of a grid of four squares on the left, with the bottom left square containing a smiley face. To the right of the squares is the text "OR Technology" in a bold font, followed by the words "Digital X-ray and Imaging Solutions" in a smaller font. There are also some Chinese characters in the image.

Section 5 510(k) Summary

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:	1 October 2013
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 code:	MQB at 21 CFR Part 892.1650LLZ at 21 CFR Part 892.2050
Predicate devices:	K083645 RadStar Digital Imaging System (5-Star Medical, Inc.)K102349 AeroDR System (Konica Minolta Medical & Graphic, Inc.)
Description of thedevice:	The dicomPACS®DX-R with flat panel digital imaging system consists oftwo components, the dicomPACS®DX-R software for viewing capturedimages on a Windows based computer, and one of three solid state X-rayimaging devices: Toshiba FDX4343R, Toshiba FDX3543RP, or KonicaMinolta AeroDR P-11 (1417HQ). The system will display high qualityimages in less than five seconds over a wide range of X-ray dose settings.The software has the following characteristics: The dicomPACS® DX-Rsoftware runs on an off-the shelf PC which forms the operator console.Images captured with the flat panel digital detector are communicated tothe operator console via LAN or WLAN connection, depending on themodel and the user's choice. dicomPACS®DX-R software uses thesoftware API of the panel manufacturers to control the flat panels and toreceive and to calibrate image data. The dicomPACS® DX-R software isan independent product for the acquisition, processing and optimisation ofX-ray images (raw images) provided by flat panel (DR) systems or CRsystems. In general, such software is also called „console software" as it isinstalled on the so-called „console PC" of the imaging device.dicomPACS® DX-R carries out the image processing of the raw imagesprovided by the particular device and provides the radiographer / X-rayassistant with an optimum workflow for their work.

Intended use of thedevice:	The dicomPACS® DX-R with flat panel digital imaging system is intendedfor use in generating radiographic images of human anatomy. This deviceis intended 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 wouldbe contrary 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 K091364. One flat panelof the proposed device is identical to that of the second predicatedevice. Apart from that, all panels share similar technical parameters aswell as the same materials and conversion technique. All panels havebeen previously cleared by FDA.
Summary ofTechnologicalCharacteristics	The three panels have the following specifications;Konica Minolta AeroDR Pixel Size 175µm, 1994 x 2430 Pixels.Toshiba FDX4343R, Pixel size 143µm, 3008(H)×3072(V) PixelsToshiba FDX3543RP, Pixel size 143µm, 2448(H)×2984(V)
Summary of Findingsfrom Non-ClinicalTesting	Biocompatibility testing was conducted: In-vitro cytotoxicity,intracutaneous reactivity, and irritation/delayed type hypersensitivity.(Patient contact is rare and incidental). Electrical safety and EMC testingwas conducted 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.
Summary of Findingsfrom Review of Clinicallmages	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:August 6, 1999 was conducted successfully.
Conclusion:	There are no significant differences between the dicomPACS® DX-R withflat panel 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 deviceis determined to be substantially equivalent to the referenced predicatedevices currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.

November 5, 2013

Oehm Und Rehbein Gmbh % Franziska Guenther Assistant to the Management Neptunallee 7c Rostock, Mecklenburg-Vorpommern 18057 GERMANY

Re: K131211

Trade/Device Name: dicomPACS® DX-R with flat panel Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: Class II Product Code: MQB Dated: October 01, 2013 Received: October 03, 2013

Dear Franziska Guenther:

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

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Page 2- Franziska Guenther

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.fdaggov/MedicalDevices/Resourcesfor You'lndustry 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 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,

Smh.7)

for

Janine M. Morris 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: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131211

Device Name

dicomPACS® DX-R with flat panel

Indications for Use (Describe)

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)

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.