Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information. Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography 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.
Device Story
IMAS is a software application for digitizing film images and managing DICOM data. Input: image data from film digitizers connected via SCSI. Operation: user logs in, creates patient/study records, instructs digitizer to scan, groups data, and transmits to DICOM destinations. Review features: image reorientation (flip/rotate), window/level adjustment, zoom, and manual segmentation of multi-image film sheets. Used in hospitals, imaging centers, and reading practices by clinicians/staff. Output: DICOM-compliant images/data sent to PACS/workstations. Benefits: facilitates digital archiving and teleradiology workflows for film-based imaging.
Clinical Evidence
No clinical data. Validation performed via extensive software testing by programmers, non-programmers, quality control staff, and potential customers.
Technological Characteristics
Software application running on Windows NT, 2000, or XP workstations. Connectivity: SCSI interface to film digitizers; DICOM network protocol for output. Features: manual image manipulation (window/level, zoom, rotation, segmentation).
Indications for Use
Indicated for use in hospitals, imaging centers, and radiologist reading practices to acquire digitized film images, manage patient/study demographics, and transmit data to DICOM-compliant systems. Contraindicated for primary interpretation of lossy compressed mammography images or digitized film screen mammography 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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NOV -8 2004
# 510(k) SUMMARY KO42700
In accordance with the provisions of the Safe Medical Device Act of 1990, eRAD ImageMedical Corp., is providing a summary of safety and effectiveness information regarding the Image Medical Acquisition Station (IMAS), Picture Archiving and Communications System, digitized film acquisition software application.
- 1.1 Company Identification
ERAD/ ImageMedical Corp. 1132 W. Hamilton Street, Suite 312 Allentown, PA 18101 Establishment Registration: 2954766 Owner Operator Number: 9042966 Contact: Jim Connors, Vice President, Product Management Tel: (864) 234-7430 ext. 106 Fax: (864) 234-7412
- 1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel/fax: (510) 276-2648 Cell: (510) 388-5001 Email: regman10@comcast.net
- 1.3 Date of Submission
September 27, 2004
- 1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name: (IMAS)
PACS Soft-copy reading and acquisition system Image Medical Acquisition Station
- । .5 Substantial Equivalence
Image Medical Acquisition Station (IMAS) software is substantially equivalent
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to the to iCRco's Xscan32 (K002911) and Merge/eFilm's eFilm Scan (K020995
#### Device Description and Intended Use 1.6
IMAS is a software application used to acquire image data from film digitizers and send it to DICOM-compliant devices. IMAS executes on a Microsoft Windows NT, 2000 and XP workstation that is connected to a film digitizer via a SCSI cable. When IMAS initializes, it obtains some settings information from the film digitizer, and displays a user interface. From the user interface, a user logs onto IMAS using an account ID and password. Once logged into IMAS, the user has the ability to create patient and study information, instruct the film digitizer to scan one or more sheets of film and download the image data, group the data from one or more films into a folder, and send the resulting information to one or more configured destinations via DICOM.
When IMAS receives the image data from the film digitizer, it appears on the workstation monitor for review. At this point, the user can reorient the image by flipping and rotating it, adjust the window and level setting, or apply a zoom factor to it. If the digitized image is of a sheet of film containing multiple images, the user can separate the image into one or more images by defining the area of each image and creating a new image from the data in the selected area.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography 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.
#### 1.7 Software Development
ERAD/ImageMedical Corp., certifies that the Image Medical Acquisition Station (IMAS) software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information to the indented users.
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#### Safety and Effectiveness 1.8
### General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indications for use.
The hardware components specified (but not supplied) are all "off the shelt" computer components.
### Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
### Substantial Equivalence:
IMAS has Indications for Use and a Target Population similar to other medical image devices, including iCRco's Xscan32 (K002911) and Merge/eFilm's eFilm Scan (K020995). All of the functions IMAS performs are available in at least one of the listed substantially equivalent devices. In most cases, the function is available in all of them. There are no significant differences between IMAS and the collective functions of all the predicate devices. See section E for additional information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# NOV - 8 2004
ERAD Image Medical Corporation % Mr. Gary J. Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
· Re: K042700
Trade/Device Name: Image Medical Acquisition Station (IMAS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 27, 2004 Received: September 30, 2004
Dear Mr. Allesebrook:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becaled been is substantially equivalent (for the indications for use stated in above and have acteam.in arketed predicate devices marketed in interstate commerce prior to the cholosure) to regally manative processed Device Amendments, or to devices that have been May 20, 1770, the charaneneully and 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 approval or a premations of the Act. The general controls provisions of the Act device, subjoct to the generation, 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 rice is oldsmod (ots such additional controls. Existing major regulations affecting your Apploval), It they of casyeer 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 least be advised mar 1271 5 issumited in 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 redular statues and regulations and listing 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) (21 CFR Part 801); 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) This letter witi anow you to obgin maneering of substantial equivalence of your device to a legally premaired 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 If you desire specific advice for your ac room 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 Also, please note the regulation on your responsibilities under the Act from the 807.97). Tou may onain other general markers, and Consumer Assistance at its toll-free number (800) DVNSloll or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmamain.html
Sincerely 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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510(k) Number (if known): 长۵५2700
#### eRAD/ImageMedical Corp., Image Medical Device Name: Acquisition Station (IMAS), Picture Archiving and Communications System
Indications For Use:
Image Medical Acquisition Station (IMAS) is a PACS and teleradiology software application used to acquire digitized film images, add and modify patient and study demographics, and transmit the results to DICOM PACS systems, archives and workstations. IMAS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Image Medical Acquisition Station (IMAS) is for use in hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography 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.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
OR
Over-the-Counter Use
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042700
(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.
