(190 days)
No
The summary describes standard image acquisition and processing software for digital X-ray systems and does not mention any AI or ML capabilities.
No
This device is for generating radiographic images for diagnostic purposes, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for "generating radiographic images of human anatomy" and to "replace film/screen systems in all general purpose diagnostic procedures." The purpose of generating radiographic images for diagnostic procedures is to aid in the diagnosis of medical conditions.
No
The device description explicitly states that the system consists of two components: the software and one of three solid state X-ray imaging devices (hardware).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy" and "to replace film/screen systems in all general purpose diagnostic procedures." This describes an imaging system used to visualize internal structures of the body, not a device that performs tests on biological samples (like blood, urine, or tissue) outside of the body to diagnose conditions.
- Device Description: The description details a system consisting of software for viewing images and solid-state X-ray imaging devices. This aligns with an imaging system, not an IVD.
- Input Imaging Modality: The input modality is X-ray, which is an imaging technique, not a method for analyzing biological samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to create images, which are then interpreted by qualified medical personnel.
N/A
Intended Use / Indications for 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.
Product codes
MQB, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Images from all three panels were reviewed by a US Board Certified Radiologist. 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. A clinical study as described in the FDA Guidance Document Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices Document issued on: August 6, 1999 was conducted successfully.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083645 RadStar Digital Imaging System (5-Star Medical, Inc.), K102349 AeroDR System (Konica Minolta Medical & Graphic, Inc.)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
| Submission
Correspondent: | Oehm und Rehbein GmbH
Contact: Franziska Günther
Phone: (49) 381 36 600 500
Email: franziska.guenther@or-technology.com |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3006542593 |
| Submission Sponsor: | Oehm und Rehbein GmbH
Neptunallee 7c
18057 Rostock
GERMANY
Phone: (49) 381 36 600 500
Fax: (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 892.1650
LLZ 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 the
device: | 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. |
| | |
| Intended use of the
device: | 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. |
| Substantial
equivalence to
predicate devices: | All three receptor panels are identical in structure and share nearly
identical Indications for Use. The included software offers the same
functions as previously cleared in our software K091364. One flat panel
of the proposed device is identical to that of the second predicate
device. Apart from that, all panels share similar technical parameters as
well as the same materials and conversion technique. All panels have
been previously cleared by FDA. |
| Summary of
Technological
Characteristics | 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) Pixels
Toshiba FDX3543RP, Pixel size 143µm, 2448(H)×2984(V) |
| Summary of Findings
from Non-Clinical
Testing | Biocompatibility testing was conducted: In-vitro cytotoxicity,
intracutaneous reactivity, and irritation/delayed type hypersensitivity.
(Patient contact is rare and incidental). Electrical safety and EMC testing
was conducted in compliance with IEC 60601-1 and IEC 60601-1-2.
Software validation and risk analysis was conducted in compliance with
FDA guidance documents. The suppliers of the respective panels
performed MTF, DQE, linearity, and resolution measurements. |
| Summary of Findings
from Review of Clinical
lmages | Images from all three panels were reviewed by a US Board Certified
Radiologist 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. A clinical study as
described in the FDA Guidance Document Guidance for the Submission of
510(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 with
flat panel digital imaging system and the predicate devices and therefore,
dicomPACS® DX-R with flat panel does not raise any questions regarding
safety and effectiveness. 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 currently on the market. |
1
2
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
3
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
4
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)