The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, CT, MRI, US, R/F units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.
Device Story
Hipax Medical Imaging Software is an autonomous PACS workstation application running on Windows 2000/XP. It receives medical images (CT, MRI, CR, US, endoscopy) via DICOM network, video sources, or digitizers. The software provides tools for image management, display, and processing, including window leveling, ROI definition, cine-loop, measurements, and Multiplanar Reconstruction (MPR). It supports DICOM worklists, image transmission, and storage on local disks, networks, or optical media (CD/DVD). Used by radiologists, orthopedists, and clinicians in clinical settings to facilitate image review and clinical decision-making. The software does not contact the patient or control life-sustaining equipment; it serves as a tool for expert human interpretation of medical images.
Clinical Evidence
Bench testing only. No clinical data provided. Software functionality was verified through internal software test procedures and documented test forms as part of the development process.
Technological Characteristics
Stand-alone software; runs on Windows 2000/XP; hardware-agnostic (user-provided). Supports DICOM 3.0 connectivity. Features include window leveling, ROI, MPR, zoom, and rotation. Copy protection via hardware dongle. No patient contact; no life-sustaining control.
Indications for Use
Indicated for medical image processing and communication for trained medical professionals including radiologists, orthopedists, clinicians, and technologists. Supports images from CR, DR, CT, MRI, US, RF, and secondary capture devices. Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images.
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/2 description: The image shows the word "HIPAK" in a stylized font. The word is written in all capital letters and appears to be slightly curved. The letters are bold and have a textured appearance, possibly indicating a rough or grainy surface. The word is surrounded by a dark outline, which gives it a three-dimensional effect.
Steinhart Medizinsysteme GmbH
## 510(k) Summary
Summary of functions of the device and its major components provided as part of the Device Summary of functions of the device and its major componing to the Guidance for the Submission of Description for Thir 70 : Modical Image Management Devices, 2000.
| Date: | July 27th 2005 |
|------------------------|----------------------------------------------------------------------------|
| Company Name: | Steinhart Medizinsysteme GmbH |
| Address: | Grubstrasse 6-8<br>D-79279 Voerstetten<br>Germany |
| Contact Person: | Martina Steinhart |
| E-Mail: | sales@hipax.de |
| Phone: | +49-(0)-7666-90070 |
| Fax: | +49-(0)-7666-900711 |
| Device Trade Name: | HIPAX Medical Imaging Software |
| Device Common Name: | Picture Archiving Communications System (PACS |
| Product Code: | LLZ |
| Regulation No. | 892.2050 |
| Device Classification: | Class II |
| Predicate Devices: | Radworks Medical Imaging Software (K962699)<br>eFilm Workstation (K012211) |
#### Device Description
The Hipax Medical Imaging Software is an autonomous software with The Hipax Medical Imaging Soltware is an autonomicas oringer Microsoft Windows 2000/XP
the exception of a dongle for copy protection. It is running under requirements and the exception of a dongle for oopy protocion. It is ranimaly inimum system requirements and supporting the Windows 2000/XP operating system.
The Hipax Medical Imaging Software has an open system architecture consisting of a basic The Hipax Medical miaging Ooltware his an open of the research and the mage acquisition, storage and communication to be added as an option.
The functions of the Hipax Medical Imaging Software correspond to the features described for the The functions of the Hipax Medical image, for example, from CT, MRI, CR, US, Predicate Devices. Displaying any medical Imaging Software offers features endoscopy, gastroscopy, and other medical specialists (e.g. window leveling, ROIs, edge routinely used by Tadiologists and other modifal op Scalless, cine-loop, measurement, writing and marking, Childrioument, 2001Itiplanar Reconstruction is available as an option.
histogram etc.). Multipland Reconstruction is division as an Sparare or the eFilm Workstation, the Like the Predicale Devices, the Rudions Moulan mage acquisition from video sources (Video Hipax Medical Innaging Soltware onero for Intege beep.
Module) digitizers (X-ray Digitizing Module), or CR systems (CR-Connection Module), Within a Module) digitzels (X-ray Digitzing Modic, of UN costs and received using the DICOM
network DICOM worklists can be received and images can be sent and liney programs was nework DICOM worklists can be recorved and inisges who inistations or other Hipax programs via protocol. Image exchange between two remote hipax of using the Hipax DICOM Communication phone lines, broadband, salente, cle. can be carrou out as oftware. The DICOM Email module, which is a modile, which is also part of the Nadworks Modes can be compressed and encrypted. The DICOM
is available to transmit images as Emails. Images can be images an he virithe is available to transmit mages as Emails: images can be written in the written Print Module supports DICOM 3.0 primary. Osing the Patient Station of Children on CD to be handed out to
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# 510(k) Summary
on digital media, e.g. DVD. To burn CDs or DVDs automatically, a CD/DVD robot can be connected.
### Intended Use
The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, CT, MRI, US, R/F units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD. Lossy compressed mammographic mages 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.
Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.
#### Technological Characteristics
The Hipax Medical Imaging Software is a stand-alone software, like the Predicate Devices. It can be used on more than one hardware platform. As long as minimum hardware requirements are met, the user is free to choose his/her own hardware platform.
The Hipax Medical Imaging Software as well as the Predicate Devices allow digital image processing and measurement capability.
The Hipax Medical Imaging Software nor contacts the patient, neither controls any life-sustaining devices. Physicians providing the adequate expert knowledge for competent human intervention interpret images and information being displayed and/or printed.
#### Testing
The Hipax Medical Imaging Software is tested according to the specifications that are documented in an own description (Description of the software test procedures) and the corresponding Softwaretest forms. Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4).
#### Conclusion
The Hipax Medical Imaging Software is a medical device. It has the same indications for use and target population as the legally marketed Predicate Devices.
The Hipax Medical Imaging Software has the same technological characteristics as the Predicate Devices.
This premarket notification describes the characteristics of the Hipax Medical Imaging Software in sufficient detail to assure substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steinhart Medizinsysteme GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 · Re: K052411 Trade/Device Name: Hipax Medical Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2005 Received: August 29, 2005
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w ove 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 the chercours) to e enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1770, and characteriting 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 do not require upproval or a 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 If your de riot is onestilia (200 as 10) additional controls. Existing major regulations affecting your Apple rally it after 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 I tease or as not is a determination that your device complies with other requirements of the Act or any I Drinas made 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
Continued and consequence The PDA finding of substantial courvalence of your dev This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FD finding of substantial equivalence of your premarket notification. The FDA finding of substantial equivalence of your device to angle your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) - 11 Feb 2017)
contact the Office of Compliance at one of the following numbers, based on the reg the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation information on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in the more
Division of Small Manufacturers, International and Consumer Assistance at its toll-free num Division of Small Manafastar at its Internet address. 036-2041 of (501) of (501) 11301) or vindex.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Nancy of Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Office of Devices and Radiological Health
Enclosure
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# Indications for Use
Kosta di li 510(k) Number (if known):
Hipax Medical Imaging Software
Indications for Use:
Device Name:
The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, DR, CT, MRI, US, RF units, secondary capture devices as scanners, video sources, etc. lmages can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD.
. . .
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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.
Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
Page 1 of 1
(Division Sign-Off) #
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052411
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.
