510(k) Report

510(k) · Cleared

Cleared

Orion Digital Imaging System

K012490510(k) TraditionalCleared Feb 12, 2002193-day reviewClass II21 CFR 892.1650

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

Infimed, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Feb 12, 2002 as substantially equivalent to K963037 (Infimed, Inc., 1996) and 1 other predicate after a 193-day review. Its family tree reaches back 1 generation to 1991. 33 later devices descend from it.

Decided
Feb 12, 2002
Review
193 days
Class
Class II
Product code
OWB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K911454 (1991). 2 ancestors in all. 33 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor2006: 2 descendants cleared2007: 1 descendant cleared2010: 2 descendants cleared2008: 2 descendants cleared2019: 5 descendants cleared2011: 4 descendants cleared2013: 2 descendants cleared2017: 3 descendants cleared2012: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2026: 3 descendants cleared2022: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant clearedK911454 · FC2000 · S & S Inficon, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants K911454 · FC2000 · S & S Inficon, Inc. · 19910+5
  1. Root · 1 generation backK911454 FC2000S & S Inficon, Inc. · 1991
  2. This deviceK012490 Orion Digital Imaging SystemInfimed, Inc. · 2002
  3. Descendant · cites it directly · 22 of its ownK093066 I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
  4. Descendant · 2 generations on · 17 of its ownK103416 Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
  5. Descendant · 3 generations on · 15 of its ownK130318 Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013
  6. Descendant · 2 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
  7. Descendant · 3 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 22010: 22011: 42012: 12013: 22016: 12017: 32018: 12019: 52020: 22022: 12023: 12025: 22026: 3
2006high 5 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 33 · See all
  • K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010 · cites it directly22descendants
  • K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011 · 2 generations on17descendants
  • K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed · 2013 · 3 generations on15descendants
  • K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 2 generations on6descendants
  • K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911454FC2000S & S Inficon, Inc.1991—
0 (this device)K012490Orion Digital Imaging SystemInfimed, Inc.2002—
+1K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.2010—
+2K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc.2011—
+3K130318Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Varian Medical Systems, X-Ray Products-Infimed2013—
+2K162529DigiX FDXAllengers Medical Systems Limited2017—
+3K192541DigiX FDXAllengers Medical Systems Limited2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200820
201020
201140
201210
201320
201610
201730
201810
201950
202020
202210
202310
202520
202630
FIG. 1 — Lineage of K012490, 1991–2026Source: 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), 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 OWB? 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 OWB device

  1. #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 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? (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
*K963037Patriot
Summary page 1
…sions drawn from comparison: The Orion fluoroscopic imaging system can be considered to be substantially equivalent to the InfiMed GoldOne Fluoroscopic System ( 510(k)-K963037) and the InfiMed FC2000 Fluoroscopic System ( 310(k) - K911454A). Virtually all of the features offered by either of the predicat…
Infimed, Inc.1996—
*K911454FC2000
Summary page 1
…stem can be considered to be substantially equivalent to the InfiMed GoldOne Fluoroscopic System ( 510(k)-K963037) and the InfiMed FC2000 Fluoroscopic System ( 310(k) - K911454A). Virtually all of the features offered by either of the predicate devices are offered by the Orion product. There are a number…
S & S Inficon, Inc.1991—

Also cleared against K963037: 3 other devices →

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc.201022
K070390Fluoropro RF Digital Imaging SystemVirtual Imaging, Inc.20073
K053029NDR+/Diva-DNical Spa20063
K061173Cpivision Digital Imaging SystemCommunications & Power Industries Canada, Inc.20061

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.
  • Of its descendants, K093066 (Infimed, Inc., 2010) has gone furthest, with 22 descendants of its own.
  • 3 other devices also cite its predicate K963037.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OWB

22in 2025

2007: 32008: 42009: 92010: 72011: 62012: 62013: 112014: 152015: 112016: 162017: 202018: 232019: 92020: 162021: 242022: 212023: 122024: 132025: 222026 (partial year): 15
2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007: 52 days median2008: 135 days median2009: 99 days median2010: 66 days median2011: 79 days median2012: 37 days median2013: 119 days median2014: 158 days median2015: 66 days median2016: 103 days median2017: 76 days median2018: 54 days median2019: 174 days median2020: 53 days median2021: 60 days median2022: 90 days median2023: 152 days median2024: 126 days median2025: 148 days median2026 (partial year): 221 days median
2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2008: 12013: 102014: 92015: 352016: 132017: 132018: 62019: 72020: 82021: 312022: 242023: 222024: 112025: 302026 (partial year): 42
2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007: 12011: 12012: 12013: 272014: 1032015: 2,1342016: 4,0742017: 1,6042018: 1,4492019: 1,5582020: 1,5812021: 1,9812022: 2,9322023: 7,6042024: 7,9422025: 14,008
2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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
200735201
2008413510
200999900
201076600
201167901
201263701
2013111191027
2014151589103
20151166352,134
201616103134,074
20172076131,604
2018235461,449
2019917471,558
2020165381,581
20212460311,981
20222190242,932
202312152227,604
202413126117,942
2025221483014,008
20261522142—

What is it indicated for?

The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (…

Read the full statement (141 words)

The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.

The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images ( 1024x1024) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage.

The Orion system enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963037

3 other devices cite the same predicate.

  • K030544RFX Fluroscopic Digital Imaging SystemSigma Vision, Inc. · 2003
  • K030061PS 3000 Digatal Photospot SystemPrecise Optics · 2003
  • K011624Expedio 500D R&F X-Ray SystemGE Medical Systems · 200111 recalls

More from Infimed, Inc.

14 FDA decisions under this applicant name. See the company

  • K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc. · 2011
  • K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc. · 2011
  • K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
  • K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
  • K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010

Recent decisions in OWB

The OWB category page

  • K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261413Extron 3;Extron 6DRTECH Corporation · 2026
  • K254205Zenition 30Philips Medical Systems Nederland B.V. · 2026
  • K260607Shield System (Siemens 30x40)Radiaction, Ltd. · 2026
  • K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V. · 2026

https://510kreport.com/device/K012490 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012490: Orion Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012490

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026