System, Reading, Television, Closed-Circuit
The Closed-Circuit Television Reading System is a low-vision aid that uses a camera and monitor to magnify printed text and images, enabling individuals with significant visual impairment to read and view documents at high magnification. It is classified as FDA Class 1, representing the lowest risk level, governed by general controls only without requiring premarket notification. The product code is HJG, regulated under 21 CFR 886.5820, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HJG
- Device Class
- FDA class 1
- Regulation Number
- 886.5820
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933633 | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE | Feb 22, 1994 | Substantially Equivalent | Gracefully Yours, Inc. |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mar 30, 1992 | Substantially Equivalent | Mentor O & O, Inc. |
| K920069 | MAGNI-CAM | Mar 02, 1992 | Substantially Equivalent | Innoventions, Inc. |
| K892351 | MAGNILINK SYSTEM 602 | May 26, 1989 | Substantially Equivalent | Coburn Optical Ind., Inc. |
| K892350 | MAGNILINK SYSTEM 402/5 | May 26, 1989 | Substantially Equivalent | Coburn Optical Ind., Inc. |
| K892349 | MAGNILINK SYSTEM 209 | May 26, 1989 | Substantially Equivalent | Coburn Optical Ind., Inc. |
| K892348 | MAGNILINK SYSTEM 201 | May 26, 1989 | Substantially Equivalent | Coburn Optical Ind., Inc. |
| K892347 | MAGNILINK SYSTEM 101 | May 26, 1989 | Substantially Equivalent | Coburn Optical Ind., Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.