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.
Device Story
dicomPACS is a modular Picture Archiving and Communications System (PACS) software. It acquires medical images from modalities (X-ray, CT, MRI, ultrasound, scanners, video) via DICOM or direct import. The system archives images in a database and provides a viewer for display on computer monitors. It includes tools for window leveling, rotation, zoom, measurements, and annotations. Used by radiologists and orthopaedists in clinical settings to assist in diagnosis and image exchange. It can integrate with RIS or KIS for electronic patient records. The software does not control life-sustaining devices; qualified medical personnel perform all interpretations. Benefits include centralized image management, improved workflow, and diagnostic support through image processing tools.
Clinical Evidence
Bench testing only. The device was tested according to specifications documented in the notification and conforms to the DICOM standard. No clinical data provided.
Technological Characteristics
Autonomous software system; no hardware. Runs on standard hardware platforms using MS Windows XP or MS Windows 2003 server. Conforms to DICOM standard. Modular architecture includes viewer, control center, database management, and acquisition modules. No life-sustaining control functions.
Indications for Use
Indicated for administration, archiving, improvement, and compression of medical image data for diagnosis. Intended for use by qualified medical personnel to create and diagnose radiological image data. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammographic images require FDA-approved 5 MP resolution monitors.
Regulatory Classification
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.
Special Controls
*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.
by. www.oehm-rehbein.com
# 510(k) Summary
K070618
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<br>18057 Rostock<br>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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Page 2 --
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
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## 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
Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
