MEDSCAN 12
Device Facts
| Record ID | K933632 |
|---|---|
| Device Name | MEDSCAN 12 |
| Applicant | Vidar Systems Corp. |
| Product Code | LMA · Radiology |
| Decision Date | Dec 13, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2030 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
