510(k) K103266
- Device
- ISTAND
- Applicant
- OPTOVUE, INC.
- 510(k) number
- K103266
- Product code
- HLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-03
- Date received
- 2010-11-04
- Regulation
- 886.1570
- Classification name
- Ophthalmoscope, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN J TALARICO
- Address
- 45531 Northport Loop W Fremont CA US 94538 94538
FDA Registration Numbers#
- 3009685433
- 1000391004
- 3005950902
- 3013557562
- 3013188547
- 3030447506
- 3033536319
- 3030626857
- 3010774780
- 3005744933
- 3038614464
- 2132111
- 3004095901
- 3005771344
- 3013298431
- 1316463
- 3033882233
- 3006809695
- 8043512
- 9617167
- 3043126966
- 3011898560
- 3003951061
- 1054713
- 3006252153
- 3042989733
- 3035708926
- 3011508451
- 3000268902
- 2918630
- 3012421607
- 3010000450
- 3006087789
- 3004598675
- 3003882387
- 3013403214
- 3012494290
- 3010792309
- 3004765453
- 1720747
- 3002821232
- 3001124136
- 1000181430
- 1000379039
- 3010675798
- 3010227033
- 3013436538
- 1226587
- 3004026651
- 3027556548
- 3010394097
- 2521877
Source Documents#
Other 510(k) Records For Product Code HLI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016-02-11 |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015-12-02 |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015-03-04 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | 2014-09-17 |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | 2014-04-23 |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | 2014-03-26 |
| K133892 | IVUE 500 | Optovue, Inc. | 2014-03-19 |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | 2013-02-26 |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | 2013-01-18 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012-05-11 |
| K120238 | RTVUE XR OCT | Optovue, Inc. | 2012-04-03 |
| K111531 | RHA2020 | Annidis Health Systems Corp. | 2011-07-08 |
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | 2011-02-09 |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | 2010-09-15 |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | 2010-06-17 |
Legacy Summary#
summary
FDA Review#
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