OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C

K993283 · Arnold & Richter Cine Technik · LLZ · Dec 29, 1999 · Radiology

Device Facts

• Record ID: K993283
• Device Name: OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
• Applicant: Arnold & Richter Cine Technik
• Product Code: LLZ · Radiology
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data.

Device Story

ARRI OSCAR NET/CD is a medical image digitizer and workstation; converts medical film and S-VHS tape images into DICOM digital format; enables electronic storage, retrieval, and transmission of medical image data; used by trained medical professionals in clinical environments; facilitates diagnostic image management via network or single-user workstation; supports clinical decision-making by providing digital access to diagnostic images.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Complies with DIN 6856 (Parts 1-2), EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, EN 50082-1, and EN 55022/CISPR 22. Functions as a PACS workstation for DICOM image handling. Hardware includes digitizing components for film/S-VHS input.

Indications for Use

Indicated for use by trained medical professionals to acquire, display, process, archive, retrieve, and transmit diagnostic medical images and associated information in single-user or network environments.

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

• MEDIMAGE and Cardio Viewing Station (K912275)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the ARRI logo in black and white. The logo consists of the word "ARRI" in bold, sans-serif font. To the right of the word "ARRI" is a circular design with the letters "ARD" inside. The logo is simple and modern.

K993283

## Summary of Safety and Effectiveness Information For 510(k) Submission Medical Image Digitizer

| General Information: | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | OSCAR NET/CD |
| Common Name: | Picture archiving and communications system |
| Classification Name: | Picture archiving and communications system, § 892.2050 |
| Classification: | Class II |
| Classificatin Number: | |
| Intendet use: | The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data. |
| Legally marketed device: | MEDIMAGE |
| Proprietary Name: | MEDIMAGE and Cardio Viewing Station |
| Common Name: | |
| Classification Name: | |
| Classification: | Class II |
| Classificatin Number: | |
| Date of Submission: | Nov.19.1997 |
| 510(k) Number: | K 912275 |

Standards for OSCAR NET/CD:

| 1. DIN 6856,Part1 | 5. EN 60601-1-1 |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Demands for the manufacture and the operation Of viewing apparatus for the evaluation of tansparent images in medical diagnostics. | -IEC 601-1-1 |
| | -VDE 0750 T1-1 |
| 2. DIN 6856,Part2 | 6. EN 60601-1-2 |
| Quality-guaranteeing meaures in medical Diagnostics, -testing procedures, measuring instruments | -IEC 601-1-2 |
| | -VDE 0750 T1-2 |
| 3. EN 60601-1 | 7. EN 60601-1-4 |
| -IEC 601-1 | -IEC 601-1-4 |
| -VDE 0750 T1 | -VDE 0750 T1-4 |
| 4. EN 50082-1 | 8. EN 55022 |
| -VDE 839 T82-1 | -VDE 878 T22/A1 |
| | -CISPR 22 |

N1

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 19 2000

i.V. Thomas Popp Product Group Manager Arnold & Richter Cine Technik GMBH & Co. Turkenstrasse 89 Munich 80799, By GERMANY

K993283 Re: ARRI-Oscar Net/CD (Image Work Station) Dated: September 29, 1999 Received: September 30, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Popp:

This letter corrects our substantially equivalent letter of December 29, 1999, regarding the 510(k) I his letter correct. Van buostantial) equal r the error and hope it has not caused any inconvenience.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we The nave revealy our Desires 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 to regally indificited production of to devices that have been reclassified in enal ment date of the Medical Device Inneral Food, Drug, and Cosmetic Act (Act ). Your may, therefore, accordance with the provisions of the Act. The general controls provisions of the Act. The general controls provisions of market the device, babyer to the 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 If your device is classified (see acove) and controls. Existing major regulations affecting your devices ripptorul) it inaly be babyer Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent career in the in and see compliance with the Good Manufacturing Practice requirements, as set forth in acterimmuner abounter couplement (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and the Quanty of seen regarines ( < ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = and and regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this may publish farther announces on the 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 continue 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.

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Page -2 - Mr. Popp

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Elinor b. Wycom

CAPT Daniel Schul z. 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): ____________________________________________________________________________________________________________________________________________________

Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Indications For Usc:

The Pacs Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retricve, and transmit diagnostic medical images and information about these images in a single user or network enviroment. The typical users are trained medical professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K993283

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Form 1-7