510(k) · Cleared
ClearedCirrus Photo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · OBO Tomography, Optical Coherence
Cleared on Jun 18, 2012 as substantially equivalent to K052268 (Carl Zeiss Meditec, AG, 2005) and 5 other predicates after a 326-day review. Its family tree reaches back 7 generations to 2002. 13 later devices descend from it.
- Decided
- Jun 18, 2012
- Review
- 326 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K012727 (2002). 33 ancestors in all, the oldest K946058 (1995). 13 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 5 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 4 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 3 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 2 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 1 generation backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- This deviceK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- Descendant · cites it directly · 3 of its ownK150467 Retina WorkplaceCarl Zeiss Meditec, AG · 2015
- Descendant · cites it directly · 3 of its ownK133217 Cirrus PhotoCarl Zeiss Meditec, AG · 2014
- Descendant · 2 generations on · 2 of its ownK180858 CALLISTO eyeCarl Zeiss Meditec, AG · 2018
- Descendant · 2 generations on · 2 of its ownK170638 Retina WorkplaceCarl Zeiss Meditec, AG · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · cites it directly5descendants
- K150467Retina WorkplaceCarl Zeiss Meditec, AG · 2015 · cites it directly3descendants
- K133217Cirrus PhotoCarl Zeiss Meditec, AG · 2014 · cites it directly3descendants
- K180858CALLISTO eyeCarl Zeiss Meditec, AG · 2018 · 2 generations on2descendants
- K170638Retina WorkplaceCarl Zeiss Meditec, AG · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −6 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −5 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −4 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −3 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −2 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −1 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| 0 (this device) | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| +1 | K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015 | — |
| +1 | K133217 | Cirrus Photo | Carl Zeiss Meditec, AG | 2014 | — |
| +2 | K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018 | — |
| +2 | K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 OBO? 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 OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K052268 | Visucam Pro NMSummary page 2…510(K) SUMMARY PREDICATE DEVICES The CIRRUS photo (Models 600 and'800) is substantially equivalent to the Carl Zeiss Meditec: VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Ner… | 2005 |
| * | K083291 | Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Summary page 2…, the Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K08329 1; K Il1157), the Carl Zeiss Meditec: FF450 plus Fundus Camera (K01 1877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical… | 2009 |
| * | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION… Cleared while this submission was under review Summary page 3…l coherence tomographer SD-OCT Module is the same optical coherence tomography system as in the cleared Cirrus HD-OCT Optical Coherence Tomographer, Model 4000 (K083291; K111157). The CIRRUS photo includes the fluorescein angiography (FA), and indocyanine green angiography (ICGA) functionalities of the Car… | 2012 |
| * | K011877 | FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus…Summary page 2…th Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K08329 1; K Il1157), the Carl Zeiss Meditec: FF450 plus Fundus Camera (K01 1877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470). The CIRRUS photo is subst… | 2001 |
| * | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8FSummary page 2…FL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K08329 1; K Il1157), the Carl Zeiss Meditec: FF450 plus Fundus Camera (K01 1877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470). The CIRRUS photo is substantially equivalent to these cl… | 2010 |
| * | K092470 | Optical Coherence Tomography 3D Oct-2000Summary page 2…329 1; K Il1157), the Carl Zeiss Meditec: FF450 plus Fundus Camera (K01 1877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470). The CIRRUS photo is substantially equivalent to these cleared devices with regard to indications for use and technological cha… | 2009 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 33 ancestors have a recall of any class.
- Of its descendants, K141844 (Carl Zeiss Meditec, AG, 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K052268.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomnicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and…
Read the full statement (193 words)
The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomnicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112184: Cirrus Photo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112184
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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