K994329 is an FDA 510(k) clearance for the IIVS INTEGRATED IMAGE VIEWING STATION. This device is classified as a System, Digital Image Communications, Radiological (Class I - General Controls, product code LMD).
Submitted by Terarecon,Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on May 26, 2000, 156 days after receiving the submission on December 22, 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 | K994329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1999 |
| Decision Date | May 26, 2000 |
| Days to Decision | 156 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. |