K041555 · Hologic, Inc. · LLZ · Aug 9, 2004 · Radiology
Device Facts
Record ID
K041555
Device Name
SECURVIEW DX SOFTCOPY WORKSTATION
Applicant
Hologic, Inc.
Product Code
LLZ · Radiology
Decision Date
Aug 9, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different storage and printing devices using DICOM or similar interface standards. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The SecurView DX is typically used by trained professionals, including, but not limited to, radiologists, technicians and assistants.
Device Story
SecurView DX is a multi-modality review workstation software; accepts DICOM-compliant medical images from external storage/printing devices; provides visualization, manipulation, and interpretation tools for radiologists and technicians. Operates on Windows 2000-based PC hardware with high-resolution monitors. System facilitates clinical review of mammography and other radiological images; supports lossless compressed or non-compressed image display. Output allows clinicians to interpret diagnostic images to support clinical decision-making. Used in clinical environments by trained medical staff.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Software-based workstation; runs on Windows 2000 OS; requires Intel CPU (>=2.0 GHz), >=2.0 GB RAM, >=140 GB HDD. Supports DICOM interface standards for image input/output. Utilizes high-resolution monitors. No specific algorithm architecture or hardware standards (ASTM) detailed.
Indications for Use
Indicated for trained professionals, including radiologists, technicians, and assistants, for the display, manipulation, and interpretation of DICOM multi-modality images, including screening and diagnostic 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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K041555
## SecurView DX AUG - 9 2004 510(k) Summary
Product Name: SecurView DX
Product Classification Name: Picture archiving and communication system
CFR Section: 892.2050 Product Classification Code: LLZ
Classification Panel: Radiology Class II
| Manufacturer: | Hologic, Inc.<br>36 Apple Ridge Road<br>Danbury, CT 06810 USA | | | | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | Gail Yaeker-Daunis<br>Telephone Number: (203) 731-8337<br>(203) 731-8440<br>Fax Number: | | | | |
| Date Prepared: | June 4, 2004 | | | | |
| | R. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.<br>1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 | | | | |
K033400 Seno Advantage, General Electric Medical Systems Predicate Device:
Device Description: The Hologic SecurView DX is mainly a software product. It is Device Description. The Hologie Docurity hadiology images. The Secur View DX is a used for visualization and processing of argitus two high-resolution gray start on horned multi-modality review workstation: It metades we keyboard and workstation keypad.
(FDA cleared for Mammography), 3-button mouse, keyboard and workstation keypad. (I'DA created for mailinegraphy); . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The soltware accepts mages which have occarded. Image processing is external to the Presentation Specification in the DIOON Station and and of the system or no compression at all when displaying mammography images.
The minimum computer requirements are:
Windows 2000® Operating System
Intel CPU with a clock rate of 2.0 GHz or greater
2.0 GB RAM or greater
140 GB Hard drive or greater, operating at 160 Mbs or greater
CD-ROM/R/RW, DVD+/-RW
10/100 Base TX Network Interface
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its head, representing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Mr. Richard Follett Vice President, RA/QA Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730 Re: K041555
Trade/Device Name: SecurView DX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 4, 2004 Received: June 16, 2004
Dear Mr. Follett:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your Scotton 910(t) pe device is substantially equivalent (for the indications felerenced above and nave decembined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manating to the Medical Device Americal Device of Dove commerce prior to way 26, 1776, the classified in accordance with the provisions of the Federal Food, DVA devices that have been recuasified in accordains approval of a premarket approval application (PMA). and Cosment Act (Rea) that do not require approvince approvisions of the Act. The Y ou may, dierelore, market the detires, baojet requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding, and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (see a0010) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may be subject to such additional controlly - Lines 800 to 898. In addition, FDA may be found in the Ood of I outstan ongerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not i Picase oe advised hat I DA s issualloo of a device complies with other requirements of the Act that FDA has made a deceimnation that your istered by other Federal agencies. You must comply or any Pederal Statures and regalations administered of the registration and listing (2 CFR Parth in the with an the Act STCquirements, metading, curfacturing practice requirements as set forth in the 807), laocing (21 CFR Part 601), goods and 1820), and if application of the electronic product quality systems (QD) regulation (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 will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial equive 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 (1), please If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and the regulation entitled, "Misbranding Othce of Compliance at (301) 574-1057. Floor, production of obtain. Other general by relerence to prematic nonitation - (21 OF Act may be obtained from the Division of Small Information on your responsionalisms and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free in the l Manufacturers, International and Collean.br ----------------------------------------------------------------------------------------------------------------------------------
Sincerely yours,
Nancy C. Boyden
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) No. K041555
## Indications For Use
## Device Name: SecurView DX
The Hologic SecurView DX device is intended for selection, display, manipulation,
of different The Hologic Secur View DX device is imended 10 images from a variety of different
filming and media interchange of multi-modality images and printing devices u filming and media merchange of indit-modality mages storage and printing devices using DICOM or similar interface standards.
The device used with FDA cleared monitors may be used by a trained physician for The device used with FDA cleared inomitive into of lossless and on non-compressed or non-compressed or non-compressed display, manipulation and interpretation of Nossiess compressed on the country.
mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.
The SecurView DX is typically used by trained professionals, including, but not limited The Secur View DX is typically dood of isl technicians and assistants.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|----------------------|--|
| OR | |
| Over-the-Counter Use | |
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K041555 |
|---------------|---------|
|---------------|---------|
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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.
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You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
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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.
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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.
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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.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
