510(k) Report

510(k) · Cleared

Recalled · 2008

Stereotactic Irradiation System

K904908510(k) TraditionalCleared Jun 6, 1991218-day reviewClass II21 CFR 892.5050Recalls 8

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

Northwest Medical Physics Center · IYE Accelerator, Linear, Medical

Cleared on Jun 6, 1991 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 8 times.

Decided
Jun 6, 1991
Review
218 days
Class
Class II
Product code
IYE
Recalls
8
Predicates
0

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

FIG. 1 — Lineage of K904908Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 18, 2008Not classifiedZ-2137-2008Software designA localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
Apr 7, 2006Not classifiedZ-1146-2007Software designThis correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry…
Jan 2, 2006Not classifiedZ-1145-2007Software designIsoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
May 31, 2005Not classifiedZ-1147-2007Software designWhen the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times…
Apr 28, 2005Not classifiedZ-1152-2007Software designWhen ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
Apr 11, 2005Not classifiedZ-1153-2007Software designWhen ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
Dec 30, 2004Not classifiedZ-1154-2007Software designWhen ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
Nov 30, 2004Not classifiedZ-1155-2007Software designWhen ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than…

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
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

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

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The IYE category page

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https://510kreport.com/device/K904908 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904908: Stereotactic Irradiation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904908

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026