510(k) · Cleared
ClearedI-BEAM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Oct 2, 2003 as substantially equivalent to K981424 (Nomos Corp., 1998) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1985. 4 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K851659 (1985). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
- 2 generations backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
- 1 generation backK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
- This deviceK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK041937 RestituResonant Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK111332 Clarity Obp SystemElekta, Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK121663 ClarityElekta, Ltd. · 2012
- Descendant · 4 generations on · 0 of its ownK141855 ClarityElekta, Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −2 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| −1 | K981424 | Nomos Bat Ultrasound Localization and Positioning System | Nomos Corp. | 1998 | — |
| 0 (this device) | K032100 | I-BEAM | Computerized Medical Systems, Inc. | 2003 | — |
| +1 | K041937 | Restitu | Resonant Medical, Inc. | 2004 | — |
| +2 | K111332 | Clarity Obp System | Elekta, Ltd. | 2012 | — |
| +3 | K121663 | Clarity | Elekta, Ltd. | 2012 | — |
| +4 | K141855 | Clarity | Elekta, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K981424 | Nomos Bat Ultrasound Localization and Positioning SystemSummary page 1…2 1 CFR892.5840 S ut)s t a nt i aI Eq ui va lence : NOMOS BAT Ultrasound Localization and Positioning System (K98 1424) Brainlab ExacTrac 2.0 Ultrasound Localization Sy… | 1998 |
| * | K003285 | Exac Trac 2.0 (Novalis Body Module)Summary page 1…Positioning System (K98 1424) Brainlab ExacTrac 2.0 Ultrasound Localization System (K003285) Device Description: The I-Beam Patient Positioning System provides a method for a hospital/clinic to accurately position a pat… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041937 | Restitu | 2004 | 3 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K041937 (Resonant Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K981424.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032100: I-BEAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032100
Report an extraction error
Are you the manufacturer?
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