510(k) · Cleared
ClearedAerFrame™ Alignment Laser Box (LBV2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stabilix, LLC · IYE Accelerator, Linear, Medical
Cleared on Sep 16, 2026 as substantially equivalent to K970291 (Elekta Instrument AB, 1997) after a 104-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 16, 2026
- Review
- 104 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935300 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 2 generations backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- 1 generation backK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- This deviceK261865 AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| −2 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| −1 | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| 0 (this device) | K261865 | AerFrame™ Alignment Laser Box (LBV2) | Stabilix, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K970291 | Accessories to the Stereotactic Body FramSummary page 5…dicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K970291 Accessories to the Stereotactic Body Frame IYE 510(k) Summary- K261865… | 1997 |
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 32 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K970291.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
Indications for Use (AerFrame™ Alignment Laser Box) The AerFrame™ Alignment Laser Box is indicated for use as an accessory to the AerFrame™ Patient Immobilization System to aid in patient positioning and alignment during photon-based radiotherapy setup. The Alignment Laser Box mounts to the AerFrame™ Coordinate Arch and projects visible laser reference points intended to align with marks on the patient’s skin. The device is intended for use in…
Read the full statement (234 words)
Indications for Use (AerFrame™ Alignment Laser Box)
The AerFrame™ Alignment Laser Box is indicated for use as an accessory to the AerFrame™ Patient Immobilization System to aid in patient positioning and alignment during photon-based radiotherapy setup. The Alignment Laser Box mounts to the AerFrame™ Coordinate Arch and projects visible laser reference points intended to align with marks on the patient’s skin. The device is intended for use in professional healthcare facilities by trained clinical staff. The device is used only during treatment setup while the linear accelerator is in standby mode. Final patient alignment must be independently verified using image-guided radiotherapy (IGRT) prior to treatment delivery.
Intended Patient Population / Selection Criteria:
The AerFrame™ Alignment Laser Box is indicated for patients undergoing photon-based radiotherapy setup with the AerFrame™ Patient Immobilization System when supplemental visible laser reference points are used to support patient positioning and alignment. The device is intended only for use with the AerFrame™ Coordinate Arch and is not indicated for standalone use or for use with other immobilization or alignment systems.
Contraindications / Limitations:
The AerFrame™ Alignment Laser Box is not indicated for use as the sole method of final patient alignment. The device must not be used during treatment beam delivery or gantry movement and must be removed from the AerFrame assembly and treatment area before linear accelerator beam activation or gantry rotation. Final patient alignment must be performed using IGRT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261865: AerFrame™ Alignment Laser Box (LBV2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261865
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026