ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC

K972925 · Access Radiology Corp. · LMD · Dec 5, 1997 · Radiology

Device Facts

• Record ID: K972925
• Device Name: ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
• Applicant: Access Radiology Corp.
• Product Code: LMD · Radiology
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.

Device Story

System functions as teleradiology image acquisition, storage, and distribution platform; enables remote transmission of diagnostic images. Used by healthcare professionals in clinical settings to facilitate remote radiological review. Inputs include diagnostic images; system manages routing and archiving of these files. Output consists of transmitted images available for review by clinicians. Facilitates remote diagnostic decision-making by providing access to images outside the immediate imaging facility.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Teleradiology image acquisition, storage, and routing system. Functions as a PACS (Picture Archiving and Communications System). Connectivity via network for remote image transmission.

Indications for Use

Indicated for use by healthcare professionals for the acquisition, storage, and routing of diagnostic radiological images in a teleradiology environment.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Access Radiology Corporation c/o Alan M. Green, M.D., Ph.D., J.D. M.L. Strategies, Inc. One Financial Center Boston, MA 02111

Re: K972925

Access Radiology (Framewave) Teleradiology Image Acquisition and Distribution System with (PACS) Picture Archiving and Communications System Dated: November 13, 1997 Received: November 14, 1997 Unclassified/Procode: 90 LMD

DEC = 5 1997

Dear Dr. Green:

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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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 marked 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/dsmamain.html".

Sincerely yours,

h7liau Yu
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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## 510 (k) Number (if known): k972925 Device Name: The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems

INDICATIONS FOR USE:

The ACCESS Radiology Teleradiology Image Acquisition and Distribution System with Picture and Archive Communications Systems products are intended to be used by healthcare professionals as a radiological image acquisition, storage, and routing system for remote acquisition and transmission of diagnostic images.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shind A. Seymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1972925 510(k) Number

Prescription Use_ V (Per 21 CFR 801.109)

OR

Over-The-Counter (Optional Format 1-2-96)