Rta Retinal Thickness Analyzer
FDA 510(k) K964137 · Talia Technology , Ltd.
510(k) numberK964137
Submission
- Device name
- Rta Retinal Thickness Analyzer
- Applicant
- Talia Technology , Ltd.
Washington, D.C., DC, US - Received
- October 15, 1996
- Decision date
- February 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
Other 510(k)s with product code HLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional | Optovue, Inc. | 02/11/2016SE |
| K150722 | EnFocus 2300, EnFocus 4400HLI · Traditional | Bioptigen, Inc. | 12/02/2015SE |
| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | Centervue S.P.A. | 04/23/2014SE |
| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
More from Bioptigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061674 | Rta 5 & Rta Model E Retinal Thickness AnalyzerHLI · Special | 08/23/2006SE |
| K041290 | Rta Model D Retinal Thickness AnalyzerHLI · Special | 05/24/2004SE |
| K031312 | Rta Model D Retinal Thickness AnalyzerHLI · Special | 05/06/2003SE |
| K000731 | Modification to Rta Retinal Thickness AnalyzerHLI · Special | 03/31/2000SE |
| K930518 | Talia Laser SlitHJO · Traditional | 01/25/1994SE |
Questions and answers
When was Rta Retinal Thickness Analyzer cleared by the FDA?
Rta Retinal Thickness Analyzer (K964137) received a 510(k) decision of Substantially Equivalent on February 3, 1997, 111 days after the submission was received.
What is the product code of K964137?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.