DICOMPACS DX-R WITH FLAT PANEL

K141440 · Oehm Und Rehbein GmbH · MQB · Aug 29, 2014 · Radiology

Device Facts

• Record ID: K141440
• Device Name: DICOMPACS DX-R WITH FLAT PANEL
• Applicant: Oehm Und Rehbein GmbH
• Product Code: MQB · Radiology
• Decision Date: Aug 29, 2014
• 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 persomel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the patient.

Device Story

System captures radiographic images using solid-state flat panel detectors (Thales Pixium Portable 2430 EZ, 3543 EZ, or Perkin Elmer 4336 XRpad). Detectors transmit raw image data to a Windows-based console PC via LAN or WLAN (Wi-Fi). Software performs image acquisition, processing, and optimization for display. Used in clinical settings by radiographers/X-ray assistants. Output provides high-quality diagnostic images to assist physicians in clinical decision-making. Benefits include rapid image availability (under 5 seconds) and replacement of traditional film/screen systems.

Clinical Evidence

Clinical image review performed by a US Board Certified Radiologist. Images from all three panels evaluated as clinically acceptable, high resolution, and comparable or superior to predicate devices. Clinical study conducted per FDA guidance 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (1999).

Technological Characteristics

Solid-state X-ray imaging system. Detectors: Thales Pixium Portable 2430 EZ (24x30cm, 148μm pixels), Thales Pixium Portable 3543 EZ (35x43cm, 148μm pixels), Perkin Elmer 4336 XRpad (35x43cm, 100μm pixels). Connectivity: 802.11(n) Wi-Fi and wired Ethernet. Software: Windows-based console PC. Compliance: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for generating radiographic images of human anatomy for general purpose diagnostic procedures. Intended for use by qualified medical personnel. Contraindicated when procedures are contrary to the patient's best interest. 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

• dicomPACS®DX-R (K131211)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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

| Submission<br>Correspondent: | Oehm und Rehbein GmbH<br>Contact: Franziska Günther<br>Phone: [phone]<br>Email: [e-mail] | |
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| 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: | 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 the<br>device: | The dicomPACS®DX-R with flat panel digital imaging system consists of two<br>components, the dicomPACS®DX-R software for viewing captured images on<br>a Windows based computer, and one of three solid state X-ray imaging<br>devices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable<br>3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). The<br>system will display high quality images in less than five seconds over a wide<br>range of X-ray dose settings. The software has the following characteristics:<br>The dicomPACS® DX-R software runs on an off-the shelf PC which forms the<br>operator console. Images captured with the flat panel digital detector are<br>communicated to the operator console via LAN or WLAN connection,<br>depending on the model and the user's choice. dicomPACS®DX-R software<br>uses the software API of the panel manufacturers to control the flat panels and<br>to receive and to calibrate image data. The dicomPACS® DX-R software is an<br>independent product for the acquisition, processing and optimization of X-ray<br>images (raw images) provided by flat panel (DR) systems or CR systems. In<br>general, such software is also called ",console software" as it is installed on the<br>so-called ",console PC" of the imaging device. dicomPACS® DX-R carries out<br>the image processing of the raw images provided by the particular device and<br>provides the radiographer / X-ray assistant with optimum workflow for their<br>work. The key difference between the modified device and our predicate device<br>is the panels are wireless, Wi-Fi. | |
| X-Ray Generators<br>Supported | Manufacturer<br>Sedecal, Spain<br>Stadler, Swizerland<br>Röntgenwerk Bochum, Germany<br>CPI, Canada<br>EMD Technologies<br>Control-X, Hungary<br>Shimadzu, Japan | Product Name<br>SHF and RST types<br>8X Series<br>Editor HFe401 - 801<br>Indico100, CMP 200 DR<br>EPS 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 for<br>use in generating radiographic images of human anatomy. This device is<br>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 be<br>contrary to the best interest of the patient. |
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| 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 K131211. All panels share<br>similar technical parameters as well as the same materials and conversion<br>technique. All panels have been previously cleared by FDA.<br>The key technical difference is that the new panels are wireless, using<br>standard Wi-Fi technology. |
| Summary of<br>Technological<br>Characteristics | The three new panels have the following specifications;<br>Thales Pixium Portable 2430 EZ (wireless) 24 x 30 cm, 148 $\mu$ m pixels<br>Thales Pixium Portable 3543 EZ (wireless) 35 x 43 cm, 148 $\mu$ m pixels<br>Perkin Elmer 4336 XRpad (wireless) : 35 x 43 cm, 100 $\mu$ m pixels<br>All use standard Wi-Fi communications and have wired Ethernet available. |
| Summary of Findings<br>from Non-Clinical<br>Testing | Electrical safety and EMC testing was conducted by the respective panel<br>manufacturers 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. Wireless<br>coexistence is assured via use of standard 802.11(n). Wireless<br>communication technology was chosen with the FDA wireless guidance<br>document taken into consideration. |
| Summary of Findings<br>from Review of Clinical<br>Images | 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: August<br>6, 1999 was conducted successfully. |
| Conclusion: | There are no significant differences between the dicomPACS® DX-R with flat<br>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 is<br>determined to be substantially equivalent to the referenced predicate devices<br>currently on the market |