Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners) It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Device Story
Reformat Gateway is a software application for automated medical image processing; receives original data from CT/MRI scanners or PACS; automatically reconstructs thin-section slice data into thick-section slices; generates Multi-Planar Reconstructions (MPR); distributes original or reconstructed data to other systems. Used in clinical settings by radiologists, clinicians, and referring physicians on standard PC hardware. Output allows clinicians to review, visualize, and store 3D medical images to facilitate routine diagnosis and clinical decision-making.
Clinical Evidence
Bench testing only. Validation testing confirmed device performs all input/output functions and required actions according to Software Requirements Specification (SRS). No clinical data provided.
Technological Characteristics
Software-based image processing system; operates on standard PC hardware; DICOM Version 3 compliant; hazard analysis classified as minor level of concern.
Indications for Use
Indicated for display and 3D visualization of CT and MRI medical data. Intended for use by radiologists, clinicians, referring physicians, nurses, and medical technicians for acquisition, processing, rendering, review, storage, printing, and distribution of DICOM-compliant studies.
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/1 description: The image shows the word "INFINITT" in a bold, sans-serif font, set against a black rectangular background. Below the word, there is a handwritten number "K052284" in black ink. The number appears to be a reference or identification code.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 10, 2005
Submitter's Information: 21 CFR 807.92(a)(1)
Ms. Bo Hyoung Kim, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: 82-2-2194-1688 Email: lemon@infinitt.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Reformat Gateway™ |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Product Code: | LLZ |
| Classification Name: | System. Image Processing |
#### Predicate Device: 21 CFR 807. 92(a)(3)
Reformat Gateway™ software device is substantially equivalent to the
| Manufacturer: | Voxar Limited<br>Bonnington Bond, 2 Anderson Place<br>Edinburgh, UK EH6 5 NP |
|-----------------------------|------------------------------------------------------------------------------|
| Device Name: | plug 'n view 3d, version 1.0 |
| 510(k) Number: | K 992654 |
| Decision Date: | 11/05/1999 |
| Decision: | Substantially Equivalent |
| Panel Code reviewed by: | Radiology |
| Panel Code classified by: | Radiology |
| Product Code: | LLZ |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II - 892.2050 |
# Device Description: 21 CFR 807 92(a)(4)
Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR
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Koszty
Image /page/1/Picture/1 description: The image shows the word "INFINITT" in white letters against a black background. The font is a bold sans-serif style, and the letters are evenly spaced. The text is centered in the image, and the overall impression is clean and modern.
reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.
# Indications for Use: 21 CFR 807 92(a)(5)
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners) It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.
# Technological Characteristics: 21 CFR 807 92(a)(6)
The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant images. The proposed and predicate software can be operated from a personal computer. Differences between the oroposed and predicate devices are limited to the availability of certain image viewing and editing features
The Reformat Gateway™ software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3
Validation testing was provided that confirms that Reformat Gateway™ performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS).
#### Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for the Reformat Gateway™ software contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Reformat Gateway™ device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings or feathers. The image is in black and white.
OCT 1 7 2005
Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850
Infinitt Co., Ltd % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K052284 Trade/Device Name: Reformat Gateway Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2005 Received: August 24, 2005
Dear Mr. Alletto:
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, therefor require, 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 provides of the Al 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.
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 aos not mour mark 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.
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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.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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Nancy C. Brogdon
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 Form)
510(k) Number:
K052284
Device Name:
Reformat Gateway™
Indications for Use:
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of 1
(Posted November 13, 2003)
David A. Slayton
(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 510(k) Number
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Learn the FDA Browser
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.
