510(k) · Cleared
ClearedMagellan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense, Ltd. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 24, 1998 as substantially equivalent to K954395 (Biosense, Ltd., 1995) after an 830-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 24, 1998
- Review
- 830 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954395 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954395 Carto SystemBiosense, Ltd. · 1995
- This deviceK961903 MagellanBiosense, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954395 | Carto System | Biosense, Ltd. | 1995 | — |
| 0 (this device) | K961903 | Magellan | Biosense, Ltd. | 1998 | — |
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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K954395 | Carto SystemSummary page 1…omputer (per 21 CFR 870.1425) Common device name: Location system Legally marketed device to which ~ Biosense CARTO system substantial equivalence is being 510(k) No. K954395 claimed The Magellan system is a subset of the CARTO system. The CARTO system consists of the location system and the viewing s… | 1995 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K954395.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The MAGELLAN™ system, which is comprised of a medical workstation, 2 magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions: process and display pre-aperatively radiographic images on & monitor; provide intra-operative image control based on the position and orientation of a user ditected tool; allow for the…
Read the full statement (244 words)
The MAGELLAN™ system, which is comprised of a medical workstation, 2 magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions:
process and display pre-aperatively radiographic images on & monitor;
provide intra-operative image control based on the position and orientation of a user ditected tool;
allow for the integration and usage of the Blosense magnetic locatiou systcur and a range of different tool attachments; and
store/retrieve image data on computer access mediu (c.g. hard disks, archive media)
Circumstunces:
The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considercd, and also during surgery when:
the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy;
the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery;
the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotialed, or
the target delineation is important and will not move significantly during the implementation of the approach (e.g. skull-based tumors. sinus diseascs, corpus callosotomies).
1Jisease or Conditions:
The MAGELLAN™ system is indicated for paticnts who have imaged space occupying lesions or malfunctions (Loth soft tissuc and osscous) in the head.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961903: Magellan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961903
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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