510(k) · Cleared
ClearedGDX VCC with Ecc Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Aug 10, 2009 as substantially equivalent to K941705 (Carl Zeiss Meditec, Inc., 1994) and 1 other predicate after a 391-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Aug 10, 2009
- Review
- 391 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K012727 (2002). 3 ancestors in all, the oldest K941705 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 1 generation backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- This deviceK082016 GDX VCC with Ecc SoftwareCarl Zeiss Meditec, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK093521 GdxproCarl Zeiss Meditec, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K093521GdxproCarl Zeiss Meditec, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −1 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| 0 (this device) | K082016 | GDX VCC with Ecc Software | Carl Zeiss Meditec, Inc. | 2009 | — |
| +1 | K093521 | Gdxpro | Carl Zeiss Meditec, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MYC device
- #1 K261255 Kowa FM-600score 12.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941705 | Nerve Fiber AnalyzerSummary page 1…yer Normative Database PREDICATE DEVICE Company: Carl Zeiss Meditec, Inc. Device: Nerve Fiber Analyzer (K941705) Company: Carl Zeiss Meditec, Inc. Device: Stratus OCT (K030433) SECTION 5.… | 1994 |
| * | K030433 | Stratusoct with RNFL Normative DatabaseSummary page 1…eiss Meditec, Inc. Device: Nerve Fiber Analyzer (K941705) Company: Carl Zeiss Meditec, Inc. Device: Stratus OCT (K030433) SECTION 5. 510(K) SUMMARY INTENDED USE The GDx is a con… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093521 | Gdxpro | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K093521 (Carl Zeiss Meditec, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K941705.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYC
116in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYC
No recall names MYC since 2007.
Adverse event reports per year · MYC
2in 2023
MAUDE reports naming product code MYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 116 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082016 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082016: GDX VCC with Ecc Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026