510(k) · Cleared
ClearedRESCAN 700, CALLISTO eye
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · OBO Tomography, Optical Coherence
Cleared on Jan 11, 2019 as substantially equivalent to K141844 (Carl Zeiss Meditec, AG, 2014) and 1 other predicate after a 350-day review. Its family tree reaches back 9 generations to 2002. 1 later device descends from it.
- Decided
- Jan 11, 2019
- Review
- 350 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K012727 (2002). 52 ancestors in all, the oldest K870039 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 5 generations between
- 3 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 2 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 1 generation backK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- This deviceK180229 RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG · 2019
- Descendant · cites it directly · 0 of its ownK233421 Rescan 700Carl Zeiss Meditec, AG · 2024
Show all 9 generations
- Root · 9 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 8 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 7 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 6 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 5 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 4 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 3 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 2 generations backK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- 1 generation backK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
- This deviceK180229 RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG · 2019
Most influential descendants
Showing 1 of 1 · See all- K233421Rescan 700Carl Zeiss Meditec, AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −8 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −7 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −6 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −5 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −4 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −3 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| −2 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| −1 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
| 0 (this device) | K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019 | — |
| +1 | K233421 | Rescan 700 | Carl Zeiss Meditec, AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K141844 | Rescan 700, Callisto EyeSummary page 4…Name Tomography, Optical coherence Primary Predicate Device Company: Carl Zeiss Meditec AG Device: RESCAN 700, K141844 Secondary Predicate Device Company: Carl Zeiss Meditec AG Device: CIRRUS photo, K112184… | 2014 |
| * | K112184 | Cirrus PhotoSummary page 4…evice: RESCAN 700, K141844 Secondary Predicate Device Company: Carl Zeiss Meditec AG Device: CIRRUS photo, K112184 INDICATIONS FOR USE (21 CFR §807.92(a)(5)) RESCAN 700 RESCAN 700 provides non-contact, high resolution, optical… | 2012 |
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 |
|---|---|---|---|
| K233421 | Rescan 700 | 2024 | 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 17 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 52 ancestors have a recall of any class.
- Of its descendants, K233421 (Carl Zeiss Meditec, AG, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141844.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses the assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180229: RESCAN 700, CALLISTO eye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180229
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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