510(k) Report

510(k) · Cleared

Cleared

HDR 1000 Plus Well Chamber, Model 90008

K060532510(k) TraditionalCleared Apr 11, 200642-day reviewClass II21 CFR 892.5700

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

Standard Imaging, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Apr 11, 2006 as substantially equivalent to K001825 (Standard Imaging, Inc., 2000) and 1 other predicate after a 42-day review. Its family tree reaches back 1 generation to 1992.

Decided
Apr 11, 2006
Review
42 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K922554 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK922554 · Standard Imaging HDR 1000 Ion Chamber · Standard Imaging, Inc. · 19921990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K922554 · Standard Imaging HDR 1000 Ion Chamber · Standard Imaging, Inc. · 19920
  1. Root · 1 generation backK922554 Standard Imaging HDR 1000 Ion ChamberStandard Imaging, Inc. · 1992
  2. This deviceK060532 HDR 1000 Plus Well Chamber, Model 90008Standard Imaging, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922554Standard Imaging HDR 1000 Ion ChamberStandard Imaging, Inc.1992—
0 (this device)K060532HDR 1000 Plus Well Chamber, Model 90008Standard Imaging, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K060532, 1992–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 JAQ? 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 JAQ device

  1. #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K001825Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion ChamberStandard Imaging, Inc.2000—
*K922554Standard Imaging HDR 1000 Ion Chamber
Summary page 1
…00 Plus Well Chamber and the Standard Imaging HDR 1000 Well Chamber, which were cleared by FDA with 510(k) premarket notifications, with numbers KOO 1825 and K922554. The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the…
Standard Imaging, Inc.1992—

Also cleared against K001825: 1 other device →

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.
  • 1 other device also cites its predicate K001825.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007: 112008: 102009: 102010: 22011: 22012: 72013: 62014: 72015: 112016: 62017: 72018: 72019: 22020: 42022: 12023: 22024: 102025: 62026 (partial year): 2
2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007: 48 days median2008: 34 days median2009: 27 days median2012: 89 days median2013: 100 days median2014: 116 days median2015: 183 days median2016: 154 days median2017: 229 days median2018: 252 days median2020: 62 days median2024: 126 days median2025: 91 days median
2007high 252 (2018) · low 27 (2009)2026

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

Recalls per year · JAQ

1in 2019

2008: 52009: 12010: 22011: 132012: 52013: 12019: 12026 (partial year): 3
2007high 13 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JAQ

3in 2025

2007: 132008: 322009: 352010: 362011: 422012: 342013: 432014: 182015: 72016: 32017: 52018: 22019: 82020: 82021: 52022: 52023: 32024: 12025: 3
2007high 43 (2013) · low 1 (2024)2025

MAUDE reports naming product code JAQ, 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
20071148013
20081034532
20091027135
20102—236
20112—1342
2012789534
20136100143
20147116018
20151118307
2016615403
2017722905
2018725202
20192—18
202046208
20210—05
20221—05
20232—03
20241012601
202569103
20262—3—

What is it indicated for?

The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of brachytherapy sources, including high-dose-rate (HDR), low-dose-rate (LDR), intravascular (IVB) and electronic (x-ray) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the labeling.

Indications for use as stated in the FDA summary.

Also cleared against K001825

1 other device cites the same predicate.

  • K013689RE-Entrant ChamberSun Nuclear Corp. · 2002

More from Standard Imaging, Inc.

10 FDA decisions under this applicant name. See the company

  • K103193Doseview 3DStandard Imaging, Inc. · 2010
  • K082773Standard Imaging Imsure Brachy QA Software, Model 91331Standard Imaging, Inc. · 2008
  • K042733Standard Imaging Pipspro QA Software SystemStandard Imaging, Inc. · 2004
  • K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc. · 2004
  • K013548Standard Imaging Ivb 1000 Well ChamberStandard Imaging, Inc. · 2001

Recent decisions in JAQ

The JAQ category page

  • K262383LumenCare AzureNucletron B.V. · 2026
  • K252717MAASTRO Rectal Applicator SetVarian Medical Systems · 2026
  • K251037Rectal ApplicatorNucletron B.V. · 2025
  • K252884Guided Aarhus Applicator SetVarian Medical Systems · 2025
  • K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

https://510kreport.com/device/K060532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060532: HDR 1000 Plus Well Chamber, Model 90008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060532

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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