EAGLESOFT CHAIRSIDE

K982422 · Eaglesoft, A Patterson Co. · LLZ · Sep 30, 1998 · Radiology

Device Facts

• Record ID: K982422
• Device Name: EAGLESOFT CHAIRSIDE
• Applicant: Eaglesoft, A Patterson Co.
• Product Code: LLZ · Radiology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public. Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices, and Generic Image Devices such as scanners. Nondiagnostic images can then be edited (i.e. resized, contrast, cropped, etc.). Images can also be easily imported and exported.

Device Story

ChairSide is a clinical dental software application used in dental offices by dentists and staff. It functions as a centralized record-keeping system for patient charts, treatment plans, clinical notes, and audio recordings. The device includes an imaging module that acquires digital images from external sources, including digital radiographic devices, video capture devices, and scanners. Users can perform basic image editing (resizing, contrast adjustment, cropping) and manage image storage, import, and export. The software serves as a single-source solution for clinical and diagnostic data management. By consolidating patient records and imaging, it assists clinicians in treatment planning and diagnostic workflows, potentially improving clinical efficiency and patient care documentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based clinical and diagnostic dental record management system. Features modules for electronic charting, audio recording, and digital image processing. Interfaces with standard dental imaging hardware (radiographic, video, scanners). Operates as a standalone software application for clinical environments.

Indications for Use

Indicated for use by dental offices to maintain patient clinical records, including hard/soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data, and for the acquisition, editing, and storage of digital images for clinical and diagnostic purposes in the general public.

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).

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Craig W. Kabbes Vice President, Engineering EagleSoft 2202 Althoff Drive PO Box 1267 Effingham, IL 62401

Re:

K982422 EagleSoft ChairSide Software Application Dated: July 1, 1998 Received: July 13, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Kabbes:

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 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 practive, 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 predication 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-fire number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Ki lian Yin

Lillian Yin, Ph.D.

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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## Statement of Indication For Use 8.0

510(k) Number (if known): _ 4 9 82422

Device Name: ChairSide

Indication For Use:

EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.

Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices, and Generic Image Devices such as scanners. Nondiagnostic images can then be edited (i.e. resized, contrast, cropped, etc.). Images can also be easily imported and exported.

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

| | Concurrence of CDRH, Office of Device Evaluation (DOE) | | | |
|------------------------------------------|--------------------------------------------------------|----|----------------------|--|
| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use | |

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K982422