510(k) Report

510(k) · Cleared

Cleared

37-702 and 37-703 PC Rainbow

K900932510(k) TraditionalCleared Dec 5, 1990280-day reviewClass II21 CFR 892.5900

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

Victoreen, Inc. · IYI Collimator, Orthovoltage, Therapeutic X-Ray

Cleared on Dec 5, 1990 after a 280-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.

Decided
Dec 5, 1990
Review
280 days
Class
Class II
Product code
IYI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2006: 1 descendant cleared2007: 1 descendant cleared2016: 6 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2018: 2 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2023: 2 descendants cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK900932 37-702 and 37-703 PC RainbowVictoreen, Inc. · 1990
  2. Descendant · cites it directly · 34 of its ownK972211 Multidos, QC6PLUSPtw-New York Corp. · 1997
  3. Descendant · 2 generations on · 33 of its ownK062817 PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
  4. Descendant · 3 generations on · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
  5. Descendant · 4 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
  6. Descendant · 5 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

1997: 12006: 12007: 12013: 12014: 22015: 12016: 62017: 32018: 22019: 22020: 12021: 12022: 32023: 22024: 22025: 32026: 3
1997high 6 (2016) · low 0 (1998)2026

Most influential descendants

Showing 5 of 35 · See all
  • K972211Multidos, QC6PLUSPtw-New York Corp. · 1997 · cites it directly34descendants
  • K062817PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006 · 2 generations on33descendants
  • K072374CompassScanditronix Wellhofer GmbH · 2007 · 3 generations on31descendants
  • K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 4 generations on23descendants
  • K153014Mobius3DMobius Medical Systems, LP · 2016 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K90093237-702 and 37-703 PC RainbowVictoreen, Inc.1990—
+1K972211Multidos, QC6PLUSPtw-New York Corp.1997—
+2K062817PTW David Imrt QC Verification SystemPtw-New York Corp.2006—
+3K072374CompassScanditronix Wellhofer GmbH20073
+4K140660MOBIUS3DMobius Medical Systems, LP20141
+5K153014Mobius3DMobius Medical Systems, LP2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
200710
201310
201420
201510
201660
201730
201820
201920
202010
202110
202230
202320
202420
202530
202630
FIG. 1 — Lineage of K900932, 1990–2026Source: 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 IYI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K972211Multidos, QC6PLUSPtw-New York Corp.199734

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, K972211 (Ptw-New York Corp., 1997) has gone furthest, with 34 descendants of its own.

How does its category compare?

All IYI devices

IYI Collimator, Orthovoltage, Therapeutic X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYI

FDA has decided no IYI device since 2007.

Median 510(k) review, days · IYI

Too few IYI 510(k)s in any year since 2007 to give a median.

Recalls per year · IYI

No recall names IYI since 2007.

Adverse event reports per year · IYI

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code IYI, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Victoreen, Inc.

40 FDA decisions under this applicant name. See the company

  • K982937Model 580-006 Radiation Therapy Ionization ChamberVictoreen, Inc. · 1998
  • K974112Vacudap, Model 2000, 2001Victoreen, Inc. · 1998
  • K973960MODEL 37-185Victoreen, Inc. · 1998
  • K964952Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997
  • K964785Veridose DiodesVictoreen, Inc. · 1997

Recent decisions in IYI

The IYI category page

  • K914821CRS Radiation Beam ScannerConsolidated Radiation Services, Inc. · 1992

https://510kreport.com/device/K900932 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900932: 37-702 and 37-703 PC Rainbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900932

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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