(60 days)
Not Found
No
The summary describes a software product for image visualization and processing, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on display, manipulation, and standard image processing techniques.
No.
The device is described as a software product used for visualization and processing of radiology images for diagnostic purposes, not for treating a disease or condition.
Yes
The device is intended for "display, manipulation and interpretation of lossless and on non-compressed or non-compressed mammographic images for screening and diagnostic mammography." The term "diagnostic mammography" directly implies a diagnostic function.
No
The device description explicitly states it includes hardware components such as "two high-resolution gray scale monitors (FDA cleared for Mammography), 3-button mouse, keyboard and workstation keypad." While it is "mainly a software product," it is not solely software.
Based on the provided information, the Hologic SecurView DX device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Hologic SecurView DX is a medical image review workstation. Its primary function is to display, manipulate, and interpret medical images (like mammograms and other DICOM images) that have already been acquired from a patient. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "selection, display, manipulation, filming and media interchange of multi-modality images" and for "display, manipulation and interpretation of...mammographic images...as well as any other DICOM multi-modality image." This is focused on image handling and interpretation, not laboratory testing.
- Device Description: The description reinforces that it's a "software product" used for "visualization and processing of radiology images."
Therefore, the Hologic SecurView DX falls under the category of medical imaging devices or picture archiving and communication systems (PACS) workstations, not in vitro diagnostics.
N/A
Intended Use / 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 image 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 and non-compressed or compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.
Product codes
LLZ
Device Description
The Hologic SecurView DX is mainly a software product. It is used for visualization and processing of Radiology images. The SecurView DX is a multi-modality review workstation. It includes two high-resolution gray scale monitors (FDA cleared for Mammography), 3-button mouse, keyboard and workstation keypad. The software accepts images which have occurred. Image processing is external to the Presentation Specification and the DIOM Station handles images without compression 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality images, mammographic images, any other DICOM multi-modality image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
typically used by trained professionals, including, but not limited physicians, radiologists, technicians and assistants.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033400 Seno Advantage, General Electric Medical Systems
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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.
36 Apple Ridge Road
Danbury, CT 06810 USA | | | | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | Gail Yaeker-Daunis
Telephone Number: (203) 731-8337
(203) 731-8440
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.
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
1
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.
2
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
3
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 |
|---|---|
| --------------- | --------- |