PATHOLOGY INSTRUMENTATION & ACCESSORIES
Device Facts
| Record ID | K823040 |
|---|---|
| Device Name | PATHOLOGY INSTRUMENTATION & ACCESSORIES |
| Applicant | Iris Remote Imaging Systems |
| Product Code | IBJ · Pathology |
| Decision Date | Jan 14, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.3600 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:(1) Phase contrast microscopes, which permit visualization of unstained preparations by altering the phase relationship of light that passes around the object and through the object. (2) Fluorescense microscopes, which permit examination of specimens stained with fluorochromes that fluoresce under ultraviolet light. (3) Inverted stage microscopes, which permit examination of tissue cultures or other biological specimens contained in bottles or tubes with the light source mounted above the specimen.
