DICOMPACS DX-R WITH FLAT PANEL

K131211 · Oehm Und Rehbein GmbH · MQB · Nov 5, 2013 · Radiology

Device Facts

• Record ID: K131211
• Device Name: DICOMPACS DX-R WITH FLAT PANEL
• Applicant: Oehm Und Rehbein GmbH
• Product Code: MQB · Radiology
• Decision Date: Nov 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

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 Story

System consists of dicomPACS® DX-R software on Windows-based PC and one of three solid-state X-ray flat panel detectors (Toshiba FDX4343R, Toshiba FDX3543RP, or Konica Minolta AeroDR P-11). Software acts as operator console; communicates with panels via LAN/WLAN. Software uses manufacturer APIs to control panels, calibrate, and acquire raw image data. Performs image processing/optimization for radiographers/X-ray assistants. Displays high-quality images in <5 seconds. Used in clinical settings to replace film/screen systems. Output aids clinical decision-making by providing diagnostic-quality radiographic images.

Clinical Evidence

Clinical image review by US Board Certified Radiologist confirmed images are clinically acceptable, high resolution, and comparable or superior to predicate devices. Clinical study conducted per FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (1999). Biocompatibility, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing performed.

Technological Characteristics

Solid-state X-ray imager. Panels: Konica Minolta AeroDR (175µm pixel size), Toshiba FDX4343R (143µm), Toshiba FDX3543RP (143µm). Connectivity: LAN/WLAN. Software: Windows-based console software for acquisition, processing, and optimization. Biocompatibility: In-vitro cytotoxicity, intracutaneous reactivity, irritation/delayed type hypersensitivity.

Indications for Use

Indicated for generating radiographic images of human anatomy in general purpose diagnostic procedures. Contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RadStar Digital Imaging System (K083645)
• AeroDR System (K102349)

Reference Devices

• dicomPACS® DX-R software (K091364)

Submission Summary (Full Text)

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KBI211

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#### Section 5 510(k) Summary

| Submission<br>Correspondent: | Oehm und Rehbein GmbH<br>Contact: Franziska Günther<br>Phone: [phone]<br>Email: [e-mail] |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3006542593 |
| Submission Sponsor: | Oehm und Rehbein GmbH<br>Neptunallee 7c<br>18057 Rostock<br>GERMANY<br>Phone: [phone]<br>Fax: [phone] |
| 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 892.1650<br>LLZ at 21 CFR Part 892.2050 |
| Predicate devices: | K083645 RadStar Digital Imaging System (5-Star Medical, Inc.)<br>K102349 AeroDR System (Konica Minolta Medical & Graphic, Inc.) |
| Description of the<br>device: | The dicomPACS®DX-R with flat panel digital imaging system consists of<br>two components, the dicomPACS®DX-R software for viewing captured<br>images on a Windows based computer, and one of three solid state X-ray<br>imaging devices: Toshiba FDX4343R, Toshiba FDX3543RP, or Konica<br>Minolta AeroDR P-11 (1417HQ). The system will display high quality<br>images in less than five seconds over a wide range of X-ray dose settings.<br>The software has the following characteristics: The dicomPACS® DX-R<br>software runs on an off-the shelf PC which forms the operator console.<br>Images captured with the flat panel digital detector are communicated to<br>the operator console via LAN or WLAN connection, depending on the<br>model and the user's choice. dicomPACS®DX-R software uses the<br>software API of the panel manufacturers to control the flat panels and to<br>receive and to calibrate image data. The dicomPACS® DX-R software is<br>an independent product for the acquisition, processing and optimisation of<br>X-ray images (raw images) provided by flat panel (DR) systems or CR<br>systems. In general, such software is also called „console software" as it is<br>installed on the so-called „console PC" of the imaging device.<br>dicomPACS® DX-R carries out the image processing of the raw images<br>provided by the particular device and provides the radiographer / X-ray<br>assistant with an optimum workflow for their work. |
| | |
| Intended use of the<br>device: | The dicomPACS® DX-R with flat panel digital imaging system is intended<br>for use in generating radiographic images of human anatomy. This device<br>is intended to replace film/screen systems in all general purpose diagnostic<br>procedures. This device is not intended for mammography applications.<br>This device is intended for use by qualified medical personnel and is<br>contraindicated when, in the judgment of the physician, procedures would<br>be contrary to the best interest of the patient. |
| Substantial<br>equivalence to<br>predicate devices: | All three receptor panels are identical in structure and share nearly<br>identical Indications for Use. The included software offers the same<br>functions as previously cleared in our software K091364. One flat panel<br>of the proposed device is identical to that of the second predicate<br>device. Apart from that, all panels share similar technical parameters as<br>well as the same materials and conversion technique. All panels have<br>been previously cleared by FDA. |
| Summary of<br>Technological<br>Characteristics | The three panels have the following specifications;<br>Konica Minolta AeroDR Pixel Size 175µm, 1994 x 2430 Pixels.<br>Toshiba FDX4343R, Pixel size 143µm, 3008(H)×3072(V) Pixels<br>Toshiba FDX3543RP, Pixel size 143µm, 2448(H)×2984(V) |
| Summary of Findings<br>from Non-Clinical<br>Testing | Biocompatibility testing was conducted: In-vitro cytotoxicity,<br>intracutaneous reactivity, and irritation/delayed type hypersensitivity.<br>(Patient contact is rare and incidental). Electrical safety and EMC testing<br>was conducted in compliance with IEC 60601-1 and IEC 60601-1-2.<br>Software validation and risk analysis was conducted in compliance with<br>FDA guidance documents. The suppliers of the respective panels<br>performed MTF, DQE, linearity, and resolution measurements. |
| Summary of Findings<br>from Review of Clinical<br>lmages | Images from all three panels were reviewed by a US Board Certified<br>Radiologist The panels produce images that are clinically acceptable. The<br>images are of excellent quality, high resolution and are comparable to or<br>better than the images from the predicate devices. A clinical study as<br>described in the FDA Guidance Document Guidance for the Submission of<br>510(k)'s for Solid State X-ray Imaging Devices Document issued on:<br>August 6, 1999 was conducted successfully. |
| Conclusion: | There are no significant differences between the dicomPACS® DX-R with<br>flat panel digital imaging system and the predicate devices and therefore,<br>dicomPACS® DX-R with flat panel does not raise any questions regarding<br>safety and effectiveness. The dicomPACS® DX-R with flat panel, as<br>designed, is as safe and effective as the predicate devices, and the device<br>is determined to be substantially equivalent to the referenced predicate<br>devices 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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)