De Novo · Granted
GrantedFluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluoptics · QDG Parathyroid Autofluorescence Imaging Device
Granted on Nov 2, 2018 as a new device type through De Novo after a 315-day review. 6 later devices descend from it.
- Decided
- Nov 2, 2018
- Review
- 315 days
- Class
- Class II
- Product code
- QDG
- Recalls
- None
6 later devices descend from it, 1 citing it directly.
- This deviceDEN170092 Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control…Fluoptics · 2018
- Descendant · cites it directly · 5 of its ownK191371 MolecuLight i:XMolecuLight, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK211901 MolecuLightDXMolecuLight, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK210882 MolecuLight I:XMolecuLight, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK251678 Swift Ray 1Swift Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK242669 SnapshotGLO (KB100)Kent Imaging, Inc. · 2025 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191371MolecuLight i:XMolecuLight, Inc. · 2019 · cites it directly5descendants
- K211901MolecuLightDXMolecuLight, Inc. · 2021 · 2 generations on1descendant
- K210882MolecuLight I:XMolecuLight, Inc. · 2021 · 2 generations on1descendant
- K251678Swift Ray 1Swift Medical, Inc. · 2026 · 2 generations on0descendants
- K242669SnapshotGLO (KB100)Kent Imaging, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics | 2018 | — |
| +1 | K191371 | MolecuLight i:X | MolecuLight, Inc. | 2019 | — |
| +2 | K211901 | MolecuLightDX | MolecuLight, Inc. | 2021 | — |
| +2 | K210882 | MolecuLight I:X | MolecuLight, Inc. | 2021 | — |
| +2 | K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026 | — |
| +3 | K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 QDG? 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 QDG device
- #1 K253303 Dendrite Imaging Systemscore 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191371 | MolecuLight i:X | 2019 | 5 |
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?
- Of its descendants, K191371 (MolecuLight, Inc., 2019) has gone furthest, with 5 descendants of its own.
How does its category compare?
All QDG devicesQDG Parathyroid Autofluorescence Imaging Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QDG
Too few QDG 510(k)s in any year since 2007 to give a median.
Recalls per year · QDG
No recall names QDG since 2007.
Adverse event reports per year · QDG
No MAUDE report names QDG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in…
Read the full statement (168 words)
The Fluoptics Fluobeam® Imaging system is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.
The Fluoptics Fluobeam® Imaging system can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.
Use of the Fluobeam® device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170092 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170092: Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170092
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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