DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM— 510(k) K913929
Substantially EquivalentOphthalmic Imaging Systems
FDA 510(k) clearance K913929 for DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM, Substantially Equivalent on 1991-11-27. Applicant: Ophthalmic Imaging Systems. Device class: 2.
Clearance details
- Applicant
- Ophthalmic Imaging Systems
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code HKI
view allMore clearances from Ophthalmic Imaging Systems
view allRecalls naming K913929
K-number listed on FDA's recall record- Z-1017-2017 — Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
- Z-1142-2017 — Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
- Z-1681-2017 — Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Z-1828-2017 — Merge Eye Station and Merge Eye Care PACS.
- Z-1246-2017 — Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913929.
Data sourced from openFDA. This site is unofficial and independent of the FDA.