IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM

K992467 · Dba Systems, Inc. · LMA · Feb 10, 2000 · Radiology

Device Facts

• Record ID: K992467
• Device Name: IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
• Applicant: Dba Systems, Inc.
• Product Code: LMA · Radiology
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

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.

Device Story

ImagClear® System digitizes analog mammography films for electronic review, archiving, and sharing. System integrates two previously cleared components: CCD-based film digitizer (16-bit grayscale, 4K x 5K matrix) and modified Galen™ software. Digitizer converts analog film to digital format; software organizes images into studies/sessions, enables bilateral/comparison displays, and facilitates creation of online mammography reports. Used by physicians or technicians in clinical settings. Output viewed on displays or stored on central file servers. System supports clinical decision-making by providing high-quality digital mammographic images for review; does not provide automated diagnosis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

CCD-based film digitizer; 16-bit grayscale resolution; minimum 4K x 5K image matrix. Software-based organization and display system. Connectivity via central file server for archiving and sharing. No specific materials or standards cited.

Indications for Use

Indicated for digitization of mammographic images for review and analysis by healthcare professionals. Not for use as the sole basis for screening or diagnosis.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*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.

Predicate Devices

• ImagClear® Film Digitizer (K932760)
• Galen™ Software (K946334)

Submission Summary (Full Text)

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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.

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## Technological Characteristics and Substantial Equivalence

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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.

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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
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M

## Performance Data

None required

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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)