(90 days)
K 912275
Not Found
No
The summary describes a device for digitizing, storing, and transmitting medical images, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as being used to acquire, display, process, archive, retrieve, and transmit diagnostic medical images, and to convert medical film/S-VHS Tape images into a digital format. These functions are for diagnostic and information management purposes, not for treating or preventing a disease or condition.
No
The device acquires, displays, processes, archives, retrieves, and transmits diagnostic medical images, but it does not perform diagnosis itself.
No
The device description explicitly states it is intended to "convert an medical film/S-VHS Tape -Image into a digital format," which implies the use of hardware (like a scanner or digitizer) to perform this conversion, in addition to the software for processing, storage, and transfer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on acquiring, displaying, processing, archiving, retrieving, and transmitting diagnostic medical images. This is related to medical imaging, not the analysis of biological samples (like blood, urine, tissue) outside the body, which is the core function of an IVD.
- Device Description: The device converts medical film/S-VHS tape images into a digital format (DICOM) for storage and transfer. This is a process related to handling and managing medical images, not performing diagnostic tests on biological specimens.
- Input Imaging Modality: The input is medical film/S-VHS tape images, which are visual representations of anatomical structures, not biological samples.
IVDs are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. This device's function is entirely centered around the management and processing of existing medical images.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical film/S-VHS Tape -Image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 912275
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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.
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
1
:
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
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 (