510(k) · Cleared

Cleared

Computer Assist Stereotactic Surg Syst, Modified

K911750510(k) TraditionalCleared Oct 15, 1991180-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Instrumentation & Diagnostics Corp.(Midco) · IYE Accelerator, Linear, Medical

Cleared on Oct 15, 1991 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Oct 15, 1991
Review: 180 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK911750 Computer Assist Stereotactic Surg Syst, ModifiedMedical Instrumentation & Diagnostics Corp.(Midco) · 1991
Descendant · cites it directly · 1 of its ownK980584 AtlasplanRadionics, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK013861 Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001

Most influential descendants

Showing 2 of 2 · See all

K980584AtlasplanRadionics, Inc. · 1998 · cites it directly1descendant
K013861Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K911750	Computer Assist Stereotactic Surg Syst, Modified	Medical Instrumentation & Diagnostics Corp.(Midco)	1991	—
+1	K980584	Atlasplan	Radionics, Inc.	1998	—
+2	K013861	Modification to Leksell Surgiplan with Atlaspace	Elekta Instrument AB	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0

FIG. 1 — Lineage of K911750, 1991–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980584	Atlasplan	Radionics, Inc.	1998	1

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, K980584 (Radionics, Inc., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)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/K911750 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911750: Computer Assist Stereotactic Surg Syst, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911750

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026