K991537 is an FDA 510(k) clearance for the SAMSUNG RAYPAX SYSTEM. This device is classified as a System, Digital Image Communications, Radiological (Class I - General Controls, product code LMD).
Submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on July 6, 1999, 64 days after receiving the submission on May 3, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2020. A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. 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..
| 510(k) Number | K991537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1999 |
| Decision Date | July 06, 1999 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMD — System, Digital Image Communications, Radiological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.2020 |
| Definition | A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. 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. |