ORIMS DIGITAL ANGIOGRAPHY SYSTEM
Device Facts
| Record ID | K952480 |
|---|---|
| Device Name | ORIMS DIGITAL ANGIOGRAPHY SYSTEM |
| Applicant | Midwest Ophthalmic Instruments, Inc. |
| Product Code | HKI · Ophthalmic |
| Decision Date | Aug 25, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Special Controls
*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
