510(k) · Cleared
ClearedMAIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centervue S.P.A. · MYC Ophthalmoscope, Laser, Scanning
Cleared on Jun 8, 2016 as substantially equivalent to K133758 (Centervue S.P.A., 2014) and 1 other predicate after a 218-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jun 8, 2016
- Review
- 218 days
- Class
- Class II
- Product code
- MYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K941234 (1995). 9 ancestors in all, the oldest K810880 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 6 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 5 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 4 generations backK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
- 3 generations backK061768 MP-1 MicroperimeterNidek Technologies Srl · 2006
- 2 generations backK092187 Maia, Model 1Centervue S.P.A. · 2010
- 1 generation backK133758 Centervue Macular Integrity AssessmentCentervue S.P.A. · 2014
- This deviceK153181 MAIACentervue S.P.A. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −6 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −5 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −4 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
| −3 | K061768 | MP-1 Microperimeter | Nidek Technologies Srl | 2006 | — |
| −2 | K092187 | Maia, Model 1 | Centervue S.P.A. | 2010 | — |
| −1 | K133758 | Centervue Macular Integrity Assessment | Centervue S.P.A. | 2014 | — |
| 0 (this device) | K153181 | MAIA | Centervue S.P.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K133758 | Centervue Macular Integrity AssessmentSummary page 5…subjects. Device description A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the… | 2014 |
| * | K061768 | MP-1 MicroperimeterSummary page 6…on: Class II Secondary Predicate Device (PD2): Nidek MP1 (secondary) 510(k) Owner: Nidek 510(k) Number: K061768 Clearance Date: 28 September 2006 FDA Product Code: HKI, HPT FDA Regulation Number:… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K133758.
How does its category compare?
All MYC devicesMYC Ophthalmoscope, Laser, Scanning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Centervue MAIA is intended for:
• measuring macular sensitivity,
• measuring fixation stability and the locus of fixation,
• providing infrared retinal imaging, and
• aiding visual rehabilitation.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a
database of known normal subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153181: MAIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153181
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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