(202 days)
Not Found
No
The description focuses on digitizing and organizing images, and explicitly states the system is composed of two previously cleared devices with no altered intended use. There is no mention of AI/ML terms or functionalities like image analysis or interpretation beyond basic viewing and organization.
No
The device is intended to digitize, view, archive, and share medical images, specifically mammographic images. It does not directly treat or diagnose a disease or condition.
No
The device is intended to digitize analog medical images, specifically mammographic images, for viewing, archiving, and sharing. It notes that it is "not as the sole basis for screening or diagnosis." While it processes images that may be used for diagnosis, the device itself performs digitization and organization, not diagnostic analysis or interpretation.
No
The device description explicitly states that the system is composed of two previously cleared devices, one of which is the "ImagClear® Film Digitizer," described as a "CCD-based digitizer." This is a hardware component, making the system not software-only.
Based on the provided information, the ImagClear® System 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. They are used to provide information for diagnosis, monitoring, or screening.
- ImagClear® System Function: The ImagClear® System digitizes analog medical images (specifically mammograms) for viewing, archiving, and sharing. It processes existing images, not biological samples from the patient.
- Intended Use: The intended use clearly states it's for digitizing images for viewing, archiving, and sharing, and specifically not as the sole basis for screening or diagnosis. This further reinforces that it's a tool for managing and viewing existing diagnostic images, not a diagnostic test itself.
The device is a medical image management and viewing system, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The ImagClear® System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LMA
Device Description
Essentially, the ImagClear® System is composed of two previously cleared devices: (1) the ImagClear® Film Digitizer, which DBA obtained FDA 510(k) clearance for use as a medical film digitizer with a mammography indication; and (2) a modified version of the previously Galen™ Software. The interfacing of these two previously cleared devices raise no new questions of safety or effectiveness because it does not alter the intended use of either device.
The first component of the ImagClear® System, the ImagClear® Film Digitizer, is a CCD-based digitizer which provides 16 bits of grayscale resolution. It produces at minimum a 4K x 5K image matrix, which is adequate for high quality mammography films. The second component of the ImagClear® System, the modified Galen™ Software, organizes the digitized mammography images into studies and sessions. The digitized mammogram studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between left and right breasts or old and new images). The software also allows physicians or technicians to create online mammography reports. In addition, the digitized mammogram studies and sessions and on-line reports may be viewed, archived on a central file server, or electronically shared with other health care professionals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
analog medical images, mammographic images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians or technicians
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)
None required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
FEB 1 0 2000
510(k) SUMMARY
DBA Systems, Inc.'s ImagClear® System
K992467
page 1 of 3
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
July 23, 1999 Date Prepared:
Name of Device and Name/Address of Sponsor
ImagClear® Mammography Review System DBA Systems, Inc. 1200 South Woody Burke Road Melbourne, Florida 32902-0550
Common or Usual Name
ImagClear® System
Classification Name
Picture Archiving and Communication System
Predicate Devices
DBA's previously cleared ImagClear® Film Digitizer (K932760) and MedImage, Inc.'s Galen™ Software (K946334)
Intended Use
The ImagClear® System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.
1
Technological Characteristics and Substantial Equivalence
K992467
Page 2 of 3
Essentially, the ImagClear® System is composed of two previously cleared devices: (1) the ImagClear® Film Digitizer, which DBA obtained FDA 510(k) clearance for use as a medical film digitizer with a mammography indication; and (2) a modified version of the previously Galen™ Software. The interfacing of these two previously cleared devices raise no new questions of safety or effectiveness because it does not alter the intended use of either device.
The first component of the ImagClear® System, the ImagClear® Film Digitizer, is a CCD-based digitizer which provides 16 bits of grayscale resolution. It produces at minimum a 4K x 5K image matrix, which is adequate for high quality mammography films. The second component of the ImagClear® System, the modified Galen™ Software, organizes the digitized mammography images into studies and sessions. The digitized mammogram studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between left and right breasts or old and new images). The software also allows physicians or technicians to create online mammography reports. In addition, the digitized mammogram studies and sessions and on-line reports may be viewed, archived on a central file server, or electronically shared with other health care professionals.
The ImagClear® System and its predicates, the ImagClear® Film Digitizer, and the Galen™ Software, have essentially the same technological characteristics. As described above, the ImagClear® System is basically the interfacing of the ImagClear® Film Digitizer with a modified version of the previously cleared Galen™ Software. No changes have been made to the previously cleared ImagClear® Film Digitizer in the combination of these two devices. Thus, the ImagClear® Film Digitizer's technological characteristics have been, for all intents and purposes, incorporated into the ImagClear® System. The principal technological distinction between the ImagClear® System's software and the previously cleared Galen™ Software is that the cleared Galen™ Software did not have all the technological specifications to accommodate a mammography indication. Accordingly, DBA and MedImage collaboratively made modifications to the cleared Galen™ Software so that the modified software could accommodate the digitized mammography images which are generated by the ImagClear® Film Digitizer.
If one reviews these software modifications, it is clear that the changes do not raise any new questions of safety or efficacy. Rather, the modifications are essentially formatting and other changes to allow the most effective presentation of the same kinds of images already included in the digitizing capabilities of the cleared film digitizer. Moreover, internal storage, archiving, and transfer capabilities of the cleared Galen™ Software have been enhanced to accommodate the mammography images.
2
In summary, while there are some differences between the In Summary, while there are to to to to teater and to device, the previously cleared Galen™
ImagClear® System and its predicate device, the previously cleared and two Imagelears bystem and tos productions as 1135, the productions of safety and efficacy.
K992467
Page 3 of 3
M
Performance Data
None required
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left, and 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
FEB 1 0 2000
DBA Systems, Inc. C/O Jonathan S. Kahan, J.D. Partner, Hogan & Harston, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K992467
ImagClear® Mammography Review System Dated: November 12, 1999 Received: November 12, 1999 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA
Dear Mr. Kahan:
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 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). 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 III (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 Practice requirements, 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 the Electronic Product 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 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"(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/dsmaldsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_ x 9 92467
Device Name: ImagClear® Mammography Review System
Indications for Use:
The ImagClear® Mammography Review System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence
f CDRH, Office of Device Evaluation (ODE)
Division Sten-Off) ivision of Reproductive, Abdominal. B and Radiological Devi 510(k) Number
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)