(59 days)
Not Found
No
The description focuses on standard PACS functionalities and manual image manipulation tools, with no mention of AI, ML, or related concepts.
No.
The device is a software application for viewing, manipulating, transmitting, printing, and storing digital radiographic image data, and it does not directly treat or diagnose a disease or condition. Its function is to support visualization and measurement for clinical professionals.
Yes
The device is described as a Picture Archiving and Communications System (PACS) software that allows clinical professionals to view, manipulate, and measure digital radiographic image data. Its predicate device, K990241 AccuImage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plugins, explicitly includes "Diagnostic" in its name. Therefore, the Hologic DR ImagePro, performing similar functions with radiographic images, is also for diagnostic use.
Yes
The device is described as a "Windows-based software application" that "runs on standard, off-the-shelf PC components." It performs functions related to viewing, manipulating, transmitting, printing, and storing digital radiographic image data, as well as image processing and measurement tools. There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, the Hologic DR ImagePro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done in vitro (outside the body).
- Hologic DR ImagePro Function: The description clearly states that the Hologic DR ImagePro is a software application for viewing, manipulating, transmitting, printing, and storing digital radiographic image data. This data is generated from imaging modalities like X-rays, which are performed in vivo (within the body).
- Intended Use: The intended use is for clinical professionals to work with radiographic images, not to analyze biological specimens.
The software's function is related to medical imaging and PACS (Picture Archiving and Communications System), which are distinct from IVD.
N/A
Intended Use / Indications for Use
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
Product codes
90 LLZ
Device Description
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant digital radiographic image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical professionals
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)
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
OCT 1 6 2003
Hologic, Inc. August 15, 2003
Hologic DR ImagePro 510(k) Premarket Notification
H. 510(k) Summary
H.1 Company Identification
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 781-999-7300
H.2 Contact Information
Daniel F. Phelan Senior Regulatory Affairs Specialist
H.3 Date of Submission
August 13, 2003
H.4 Device Identification
Proprietary Name Hologic DR ImagePro Classification Name: Picture Archiving and Communications System Regulation Number: 21 CFR 820.2050 Product Code: 90 LLZ Common/Usual Name Medical Image Management Device
H.5 Predicate Device Information
K990241 Acculmage Diagnostics Corp. AccuView Diagnostic Imaging Software Package with Plugins.
H.6 Device Description and Intended Use
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
H.7 Software
Hologic, Inc. certifies that the DR ImagePro software package is designed, developed, verified, and validated in accordance with written procedures as required by 21 CFR 820 and Hologic's quality system.
000336
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H.8 Hazard/Risk Analysis
The DR ImagePro does not contact the patient and is not intended to sustain life or control lifesustaining devices. Risk analysis has been performed throughout the development process in accordance with design control procedures. Particular attention has been paid to identifying potential hazards, assessing any potential effect on the safety of patients and the effectiveness of the device, determining the causes and effects of potential hazards, implementing mitigation measures, and to maintaining records of risk analysis and mitigation measures.
The potential risks identified through risk analysis activities are no different that those of other PACS devices. None of the risks is expected to cause or contribute to patient death or serious injury. Hologic therefore concludes that the Level of Concern posed by DR ImagePro is "minor."
| Manufacturer | Hologic, Inc. | Acculmage Diagnostics Corp |
|---|---|---|
| 510(k) Number | K990241 | |
| Proprietary Name | DR ImagePro | Accuview Diagnostic Imaging |
| Software Package with Plug-ins. | ||
| Computer Platform | Standard PC, Windows XP OS, > | |
| 2.0GHz processor, ≥ 512 MB RAM. | Standard PC, Windows 95/98/NT OS, | |
| 400MHz processor, 512 MB RAM | ||
| Communications | TCP/IP Ethernet | TCP/IP Ethernet, GPIB |
| Image Format (input) | DICOM 3.0 | DICOM 3.0, ACR NEMA 2.0 |
| Image Format (output) | DICOM 3.0 | DICOM 3.0, BMP, TIFF |
| Storage Media | PACS/Ethernet Network, Local Disk. | PACS/Ethernet Network, Local Disk, |
| CD-ROM | ||
| Display / Monitor | ||
| Requirements | > 18" Color, CRT or LCD, SXGA 1280 | |
| X 1024 | Color/Grayscale, CRT or Laptop LCD, | |
| Up to 1024 X 768 | ||
| Image Processing | Window/Level, Pan, Zoom, Grayscale | |
| Invert, Contrast Enhance, Sharpen, | ||
| Blur, Rotate, Crop, Side-by-side | ||
| Display. | Window/Level, Pan, Zoom, Variable | |
| Smooth Filter, Cine Display | ||
| Image Stitching | Merge images from the same | |
| patient/study. Manual selection of | ||
| common stitch points within images. | ||
| Software stitches user-placed | ||
| common points. | Merge images from the same | |
| patient/study (patient/study data | ||
| obtained from DICOM header). | ||
| Manual selection of common stitch | ||
| points within images. Software | ||
| stitches user-placed common points | ||
| or lines. | ||
| Line Measurement Tool | Measures distances from user-placed | |
| points on image Measurements | ||
| derived from pixel size specified in | ||
| DICOM header. | Measures distances from user-placed | |
| points on image Measurements | ||
| derived from pixel size specified in | ||
| DICOM header.. | ||
| Angle Measurement | ||
| Tool | Measures angles from user-placed | |
| points on image. | Measures angles from user-placed | |
| points on image. |
H.9 Substantial Equivalence
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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a circular border with text around the top half, although the text is not legible. Inside the circle is a stylized graphic of three bird heads facing to the right. The bird heads are connected and appear to be in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K032546 Trade/Device Name: Hologic DR ImagePro Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and
communications system
Regulatory Class: II Product Code: 90 LLZ Dated: August 15, 2003 Received: August 18, 2003
Dear Mr. Phelan:
·
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, therefore, market 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 practice, 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 may be subject to 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 of the Act or any 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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/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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B.2 Indications for Use
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.
Prescription Use
NancyC Srodon
(Division Sign-Off)
Division of Reproduct Yve. Abdom and Radiological Device 510(k) Number