510(k) Report

510(k) · Cleared

Cleared

Imagert

K942346510(k) TraditionalCleared May 15, 1995364-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

Impac Medical Systems, Inc. · IYE Accelerator, Linear, Medical

Cleared on May 15, 1995 after a 364-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
May 15, 1995
Review
364 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2001: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared2016: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK942346 ImagertImpac Medical Systems, Inc. · 1995
  2. Descendant · cites it directly · 10 of its ownK011694 ViewstationImpac Medical Systems, Inc. · 2001
  3. Descendant · cites it directly · 9 of its ownK043412 Modification to: ViewstationImpac Medical Systems, Inc. · 2004
  4. Descendant · 2 generations on · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
  6. Descendant · 4 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12004: 12012: 22014: 12016: 12021: 12022: 12023: 12025: 12026: 1
1998high 2 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 12 · See all
  • K011694ViewstationImpac Medical Systems, Inc. · 2001 · cites it directly10descendants
  • K043412Modification to: ViewstationImpac Medical Systems, Inc. · 2004 · cites it directly9descendants
  • K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · 2 generations on8descendants
  • K142142Quality ReportsSun Nuclear Corporation · 2014 · 3 generations on5descendants
  • K162468ClearCheckRadformation · 2016 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942346ImagertImpac Medical Systems, Inc.1995—
+1K011694ViewstationImpac Medical Systems, Inc.2001—
+1K043412Modification to: ViewstationImpac Medical Systems, Inc.2004—
+2K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20123
+3K142142Quality ReportsSun Nuclear Corporation2014—
+4K162468ClearCheckRadformation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200410
201220
201410
201610
202110
202210
202310
202510
202610
FIG. 1 — Lineage of K942346, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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
Get a 510(k) Report

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? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011694ViewstationImpac Medical Systems, Inc.200110
K043412Modification to: ViewstationImpac Medical Systems, Inc.20049
K980118Kodak Digital Science Oncology Image ManagerEastman Kodak Company19980

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, K011694 (Impac Medical Systems, Inc., 2001) has gone furthest, with 10 descendants 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

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—

More from Impac Medical Systems, Inc.

13 FDA decisions under this applicant name. See the company

  • K151233MonacoImpac Medical Systems, Inc. · 20159 recalls
  • K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 201411 recalls
  • K132971MonacoImpac Medical Systems, Inc. · 20134 recalls
  • K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 20127 recalls
  • K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 20123 recalls

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K942346 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942346: Imagert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942346

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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