SECOND LOOK VIEWER

K042697 · Icad, Inc. · LLZ · Nov 19, 2004 · Radiology

Device Facts

• Record ID: K042697
• Device Name: SECOND LOOK VIEWER
• Applicant: Icad, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

Device Story

Second Look® Viewer is a radiological image display system used by radiologists in clinical settings. It functions as a softcopy viewer for mammography cases previously processed by the Second Look® CAD system. Input consists of pre-computed CAD marks and mammography images retrieved via network from a CAD processing unit. The device uses a touchscreen monitor and barcode reader for user interaction. The physician scans a patient barcode to display mammograms with CAD overlays; the system allows magnification of specific image regions and review of pre-computed ultrasound results (e.g., CADStream®). The device serves solely as a viewer for pre-computed data; it does not perform diagnostic analysis itself. By providing a softcopy interface for CAD-annotated images, it facilitates efficient radiologist review of pre-computed findings, potentially aiding in the assessment of mammography cases.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intel-based computer system; touchscreen monitor; barcode reader; network connectivity to CAD processing unit; softcopy display of medical images and pre-computed CAD annotations.

Indications for Use

Indicated for display of low resolution, nondiagnostic medical images with pre-computed annotations or CAD marks for clinical review.

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).

Predicate Devices

• Consultiva™ Report Station (RS) by MiraMedica, Inc.

Submission Summary (Full Text)

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## 510(k) Summary

NOV 1 9 2004

iCAD, Inc. Submitter: 2689 Commons Blvd., Suite 100 Beavercreek, OH 45431

John Rosenstengel Contact Person:

November 18, 2004 Date Prepared:

Device Trade Name: Second Look® Viewer

System, Image Processing, Radiological Common Name:

Classification Name: Picture archiving and communications system (21 CFR 892.2050)

Predicate Device(s): Consultiva™ Report Station (RS) by MiraMedica, Inc.

Device Description: The Second Look® Viewer is composed of three primary components. The major component is the computer (1), which is supported by a touchscreen monitor (2) and a barcode reader (3). The computer is a conventional Intel based computer that is connected to the Second Look® CAD processing unit via a network. The Second Look Viewer serves no other purpose than viewer support. The physician interfaces to the software using the touch screen or barcode reader. The physician first barcodes a given patient whose mammography case has already been processed by the Second Look CAD processing unit. The viewer displays the Mammagraph™s with the pre-computed CAD marks overlayed. Second Look Viewer allows a radiologist to review Second Look® Analog CAD output, in softcopy format. The physician may touch any of the small images and see a higher resolution, magnified image along with characterization information for that image. After viewing the mammography case, the radiologist may use the Second Look® Viewer to review pre-computed ultrasound results, such as CADStream® output, if such results already exist for the case under review.

Indication for Use: The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

Technological Characteristics and Testing:

Conclusion:

Results of performance and validation testing indicate that the Second Look® Viewer is substantially equivalent to the predicate device

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 9 2004

Mr. John E. Rosenstengel "Director. Quality & Regulatory Affairs ICAD, Inc. · 2689 Commons Blvd., Suite 100 BEAVERCREEK OH 45431

Re: K042697

Trade/Device Name: Second Look® Viewer Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 30, 2004 Received: September 30, 2004

· Dear Mr. Rosenstengel:

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 reguirements 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 (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 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 Àct'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) rins letter will and wyour your e FDA finding of substantial equivalence of your device to a legally premaince notification - wesults 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 11 you dostre of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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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510(k) Number (if known): K042697

Device Name: Second Look® Viewer

Indications for Use:

The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-ofinterest or pre-computed CAD marks.

Prescription Use__X_ (Part 21 CFR 801 Subpart D) ANDYOR

Over-The-Counter Use_ (21 CFR 807 Part C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legum

lominal, 510kl N