510(k) · Cleared
ClearedCass System (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instrumentation & Diagnostics Corp.(Midco) · IYE Accelerator, Linear, Medical
Cleared on Nov 7, 1996 as substantially equivalent to K892425 (Leibinger & Fischer, Ltd., 1990) and 1 other predicate after a 223-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 7, 1996
- Review
- 223 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892425 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK892425 STP Complete Module SetLeibinger & Fischer, Ltd. · 1990
- This deviceK961484 Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco) · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892425 | STP Complete Module Set | Leibinger & Fischer, Ltd. | 1990 | — |
| 0 (this device) | K961484 | Cass System (Modification) | Medical Instrumentation & Diagnostics Corp.(Midco) | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K892425 | STP Complete Module SetSummary page 2…a. F.L. Fischer---Liebinger LP 14540 Beltwood Parkway East Dallas, Texas 75244 Product Name: STP Stereotaxic Convergent Beam Irradiation System Document Control Number: K892425 b. Radionics 76 Cambridge Street Burlington, Massachusetts 01803-0738 Product Name: X-Knife Radiosurgery System Document Control… | 1990 |
| * | K912630 | Xknife Radiosurgery SystemSummary page 2…ocument Control Number: K892425 b. Radionics 76 Cambridge Street Burlington, Massachusetts 01803-0738 Product Name: X-Knife Radiosurgery System Document Control Number: K912630 Device Description: cass Linac Radiosurgery Hardware Couchmount Stereotactic Frame Support System MIDCO has rece… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K892425.
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 | — |
https://510kreport.com/device/K961484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961484: Cass System (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961484
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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