K972886 · Segami Corp., Inc. · LLZ · Oct 1, 1997 · Radiology
Device Facts
Record ID
K972886
Device Name
MIRAGE
Applicant
Segami Corp., Inc.
Product Code
LLZ · Radiology
Decision Date
Oct 1, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The intended use of the Mirage system of image acquisition, processing and analysis is to provide the Nuclear Physician with a tool to acquire, format and store the data acquired by a camera, to display in all the traditional manners, to add three-dimensional renderings to the displays, and to display some kinetic attributes of the imaged organs or systems. The major benefits are the ease of use, the speed of processing, and the variety of display alternatives.
Device Story
Mirage is a software system for nuclear medicine image acquisition, processing, and post-processing. It accepts raw signals from scintigraphy cameras; formats data; performs tomographic reconstruction; and enables visualization/analysis. Used in clinical settings by nuclear physicians to review planar or tomographic, static or dynamic images. Output includes traditional displays, 3D renderings, and kinetic animations. Facilitates clinical decision-making by providing efficient data management and varied display alternatives for organ/system assessment.
Clinical Evidence
Clinical equivalence was evidenced by demonstrating that in clinical applications (using current or archival cases), the clinician's conclusion would not have differed substantially from those of the predicate devices.
Technological Characteristics
PC-based architecture running on Windows NT; software written in Visual C++. Functions include camera-driven acquisition, tomographic reconstruction, and post-processing/visualization. Supports patient data management. No specific hardware materials or sterilization methods listed as it is a software-only system.
Indications for Use
Indicated for the acquisition, formatting, and storage of scintigraphy camera output data. Capable of processing and displaying information in traditional formats, pseudo three-dimensional renderings, and animated sequences showing kinetic attributes of imaged organs. Intended for use by nuclear physicians.
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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# Segami Corporation
# ×972886
## 10. 510K Summary
OCT - 1 1997
## 10.1. Identification
ﻟﻤﺴﺘﻘ
10.1.1 Date of Application:
10.1.2 Manufacturing Facility:
August 4, 1997
Segami Corporation, Inc. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: (410) 531-2357 fax: (410) 531-5029
10.1.3 Contact Person :
Philippe Briandet Ph.D. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: (410) 531-2357 fax: (410) 531-5029
10.1.4 Signature
Philippe Briander
Date 08-04-97
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#### 10. 2. Device Name
ﻴﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ
10.2.1 Classification Name:
10.2.2 Common/Usual Name:
Image Processing System
Nuclear Medicine Planar and SPECT Image Processing Software
10.2.3 Proprietary Name:
MIRAGE
#### 10.3. Substantial Equivalence (Predicate devices)
The predicate devices are the ICON COMPUTER SYSTEM by Siemens Medical Systems, Inc.(Product code JWM, 510K # K914350) and SOPHY NXT by Sopha Medical Systems, Inc.(product code KPS and 501K# K913641).
Substantial equivalence was shown non-clinically by demonstrating that Generic Image Operations, Generic Tomographic post-processing, First Pass Ventriculography and Planar Gated Blood-pool Analysis did not yield substantially different results from those of the predicate devices.
Substantial equivalence was evidenced clinically by demonstrating that in the clinical applications (of current clinical cases or archival cases) the clinician's conclusion would not have differed substantially.
The technological characteristics which differ have no effect on the software's results: The Mirage system is based on the PC architecture (versus Macintosh and proprietary for predicate devices), the operating system is Windows NT (versus Macintosh and Forth), the software language is Visual C++ (versus Pascal and Forth).
The Patient Data Management went through a separate technical test in which the validity and integrity of the data was evaluated.
#### Conclusion:
The Mirage Software package is closely similar in intended use and technical characteristics to the predicate devices. The product raises no new questions regarding safety or effectiveness. Segami Corporation. Inc. concludes that the product is essentially equivalent to devices of the same classification previously approved.
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#### 10.4 Description.
Camera driven acquisition software refers to the formatting of camera signals into spatial distributions, and producing timing signals allowing camera defined acquisition or motion to proceed. The term processing refers to all manners of data manipulation, following the acquisition. including the reconstruction of tomographic volume data from multiple projection acquisitions. The term post-processing refers to image manipulation and analysis which occurs after the image (planar or tomographic, static or dynamic) has been formed. Post-processing specifically includes display methods, which determine how the user can (re)view and interpret the data.
The most crucial component for a post-processing system, which should be able to receive and handle data (images) from different origins (acquisition systems), is the Patient Data Management.
The product (Mirage) is basically a camera driven acquisition, processing and postprocessing (visualization and analysis) software system with a Patient Data Management system, to which minimal processing (e.g. tomographic reconstruction) has been added.
#### 10.5 Statement of Indication for use.
The intended use of the Mirage system of image acquisition, processing and analysis is to provide the Nuclear Physician with a tool to acquire, format and store the data acquired by a camera, to display in all the traditional manners, to add three-dimensional renderings to the displays, and to display some kinetic attributes of the imaged organs or systems. The major benefits are the ease of use, the speed of processing, and the variety of display alternatives.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized human figure with three arms raised in a wave-like pattern. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
Philippe Briandet, Ph.D. President Segami Corporation 12624 Golden Oak Drive Ellicott City, MD 21042
OCT - I 1997 Re: K972886 Mirage Nuclear Medicine Image Processing System Dated: August 4, 1997 Received: August 5, 1997 Unclassified/Procode: 90 LLZ
Dear Dr. Briandet:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Pracice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J.Liau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K972886
Device Name: Mirage
Indications for Use:
The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thavid A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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.
