(51 days)
Not Found
No
The document describes a standard PACS system with image processing features like window leveling, zoom, and measurements. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance study summaries.
No
The device is a Picture Archiving and Communications System (PACS) software used for the administration, archiving, and display of medical images for diagnosis, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used for "administration, archiving, improvement and compression of medical image data for diagnosis" and that "The data is displayed on a computer monitor for diagnosis." Also, it mentions that users "must be qualified to create and diagnose radiological image data."
Yes
The device description explicitly states "dicomPACS® is an autonomous software and involves no hardware."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- dicomPACS® Function: The description clearly states that dicomPACS® is a software system for managing, archiving, displaying, and processing medical image data acquired from imaging modalities like X-ray, CT, MRI, and ultrasound. It works with images, not biological samples.
- Intended Use: The intended use is for the administration, archiving, improvement, and compression of medical image data for diagnosis by qualified medical personnel. This is focused on interpreting visual information from imaging, not analyzing biological samples.
The text consistently describes a system for handling and viewing medical images, which falls under the category of medical imaging software or a PACS (Picture Archiving and Communications System), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.
dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
Product codes
LLZ
Device Description
dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.
dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc.
dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital X-ray, CT, MRI, ultrasound, scanners and video sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images.
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
dicomPACS® has been tested according to the specifications documented in this notification (Section 14 g). It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/12 description: The image contains the logo for dicomPACS. The logo includes the text "dicomPACS" in a stylized font, with the "PACS" portion in a lighter shade. Below the text, there are the words "Digital Image Management" in a smaller, lighter font. To the left of the text, there are two abstract graphic elements, one of which appears to be an image of a hand or bones.
510(k) Summary
Summary of functions of the device and its major components provided as part of the Premarket Notification for dicomPACS®.
| Date: | 28 February 2007 | APR 25 2007 |
|---|---|---|
| Company Name: | Oehm und Rehbein | |
| Address: | Waldemarstr. 20 g/h | |
| 18057 Rostock | ||
| Germany | ||
| Contact Person: | Franziska Günther | |
| E-Mail: | franziska.guenther@oehm-rehbein.de | |
| Tel: | +49-381-20361291 | |
| Fax: | +49-381-2036111 | |
| Device Trade Name: | dicomPACS® | |
| Device Common Name: | Picture Archiving and Communications System (PACS) | |
| Product Code: | LLZ | |
| Regulation No.: | 892.2050 | |
| Device Classification: | Class II |
Description
Predicate Devices:
dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.
HIPAX Medical Imaging Software (K052411) eFilm Workstation with Modules (K020995)
dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc.
dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard.
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Image /page/1/Picture/0 description: The image contains a logo with the text "dicomPACS" in a stylized font. Below the logo, there are smaller words that say "Digital Image Management". To the left of the text, there is a graphic of a hand with rays emanating from it, set against a black background. At the bottom of the image, the text "by www.oehm-rehbein.com" is displayed.
Intended Use
dicomPACS® is intended to be used for the acquisition, storage, communication and viewing of medical images.
dicomPACS® receives images from modalities including but not limited to digital X-ray, CT, MRI, ultrasound, scanners and video sources. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists. dicomPACS® can be integrated with an existing RIS or KIS system for an integrated electronic patient record.
All these tools are also offered by both HIPAX and eFilm.
Technological Characteristics
dicomPACS® is an autonomous software and involves no hardware. This largely applies to the predicate devices HIPAX and eFilm. There is no difference to eFilm.
dicomPACS® runs on any hardware platform meeting the minimum system requirements.
dicomPACS® can be used with the server operating systems MS Windows XP and the MS Windows 2003 server.
dicomPACS® does not control any life-sustaining devices. Specialists with adequate expert knowledge for competent human intervention interpret displayed or printed images and information.
Testing
dicomPACS® has been tested according to the specifications documented in this notification (Section 14 g). It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement.
Conclusion
dicomPACS® is a medical device. dicomPACS® provides functionality comparable to that of its Predicate Devices and is intended for the same user and patient groups as its Predicate Devices.
This premarket notification contains sufficient information to establish substantial equivalence to the Predicate Devices.
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The image is in black and white and appears to be a scan or photocopy.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Franziska Günther Assistant to the Management Oehm und Rehbein GmbH Waldemarstr. 20 g/h 18057 Rostock GERMANY
APR 2 5 2007
Re: K070618
Trade/Device Name: dicomPACS® Regulation Number: 21 CER 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 28, 2007 Received: March 5, 2007
Dear Ms. Günther:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters FDA in the center. The logo also includes the words "Centennial" and the years "1906-2006". The logo appears to be a commemorative emblem for the centennial anniversary of the Food and Drug Administration. The image also contains some text below the logo, but it is not clear enough to read.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070618
dicomPACS® Device Name:
Indications For Use:
dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.
dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
Prescription Use: × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) .
David A. Symm
(Division Sian-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number
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