510(k) Report

510(k) · Cleared

Cleared

B-400 Ceiling Mounted Possitioner, Model B-400

K990055510(k) TraditionalCleared Feb 2, 199926-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

Omega Medical Imaging, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on Feb 2, 1999 as substantially equivalent to K915592 (Fischer Imaging Corp., 1992) and 3 other predicates after a 26-day review. Its family tree reaches back 1 generation to 1988.

Decided
Feb 2, 1999
Review
26 days
Class
Class II
Product code
JAA
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K880527 (1988). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1992: 2 other ancestorsK880527 · Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm · Fischer Imaging Corp. · 19881985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors K880527 · Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm · Fischer Imaging Corp. · 19880
  1. Root · 1 generation backK880527 Ceiling Mounted Fluoroscopic C-Arm Ariel C-ArmFischer Imaging Corp. · 1988
  2. This deviceK990055 B-400 Ceiling Mounted Possitioner, Model B-400Omega Medical Imaging, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K880527Ceiling Mounted Fluoroscopic C-Arm Ariel C-ArmFischer Imaging Corp.1988—
0 (this device)K990055B-400 Ceiling Mounted Possitioner, Model B-400Omega Medical Imaging, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199710
FIG. 1 — Lineage of K990055, 1988–1999Source: 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 JAA? 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 JAA device

  1. #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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? (5)

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
*K915592Pegasus Lateral Cardiac Positioner
Summary page 2
…tic Source Assembly & Image Receptor for Fluoroscopy Variable 327to 427 Fixed at lateral center +60°/-30° (30° LAO to 120° LPO) 36" 7R” 437 89”7 Fisher Pegasus K915592 90JAA Ceiling Mounted Cardiac Positioner ‘C’-Arm to support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy V…
Fischer Imaging Corp.1992—
*K880527Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm
Summary page 2
…rdiac Positioner ‘C’-Arm to support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy Variable 34” to 50~ +45°/-90° +30°/-90° 462" 217 Ficher Ariel K880527 90JAA Ceiling Mounted Fluoroscopy C-Arm “C’-Arm (v support X-Ray Diagnostic Source Assembly & Image Receptor for Kluoroscopy…
Fischer Imaging Corp.1988—
*K923813Philips Integris V3000 Rotational Angio Function
Summary page 2
…support X-Ray Diagnostic Source Assembly & Image Receptor for Kluoroscopy Not available +90°/-90° +45°/-45° Not available Not available Philips Integras HM 3000 K923813 90JAA Ceiling Mounted C-Arm Portion *C’-Arm to support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy Varia…
Philips Medical Systems, Inc.19921
*K970947B-350 Ceiling Mounted C-Positioner
Summary page 2
…ling Mounted ‘C’ Positioner ‘C’-Arm to support X-Ray Diagnostic Source Assembly & Image Receptor for Fluurvscopy Variable 46” to 56” +/- 180° +145°/-55° Omega B350 K970947 J0JAA Ceiling Mounted ‘C’ Positioner *C’-Arm to support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy Vari…
Omega Medical Imaging, Inc.1997—
*—Fisher’s CPS Ceiling Mounted Imaging System
Named without a submission number
—

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?

  • 1 of the 4 ancestors has a recall of any class.

How does its category compare?

All JAA devices

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

FDA decisions per year · JAA

2in 2025

2007: 12008: 62010: 12011: 42012: 12013: 62014: 62015: 32016: 22017: 12018: 32019: 62020: 42021: 62022: 12023: 22024: 32025: 22026 (partial year): 1
2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAA

89in 2024

2008: 18 days median2011: 48 days median2013: 129 days median2014: 276 days median2015: 197 days median2018: 30 days median2019: 49 days median2020: 39 days median2021: 104 days median2024: 89 days median
2007high 276 (2014) · low 18 (2008)2026

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

Recalls per year · JAA

4in 2025

2007: 352008: 212009: 182010: 62011: 72012: 22013: 32014: 12015: 12016: 72017: 32018: 12019: 22020: 22021: 22022: 52023: 92024: 22025: 4
2007high 35 (2007) · low 1 (2014)2026

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

Adverse event reports per year · JAA

33in 2025

2007: 9,5172008: 9,4842009: 12,0402010: 5,8032011: 14,0002012: 11,6842013: 13,7062014: 10,2652015: 2,9222016: 352017: 562018: 362019: 492020: 392021: 352022: 342023: 412024: 252025: 33
2007high 14,000 (2011) · low 25 (2024)2025

MAUDE reports naming product code JAA, 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
20071—359,517
2008618219,484
20090—1812,040
20101—65,803
2011448714,000
20121—211,684
20136129313,706
20146276110,265
2015319712,922
20162—735
20171—356
2018330136
2019649249
2020439239
20216104235
20221—534
20232—941
2024389225
20252—433
20261—0—

What is it indicated for?

This device is intended to support the X-Ray Diagnostic Source Assembly and the Image Receptor. It is not designed nor intended to be used in any General Purpose X-Ray System.

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

More from Omega Medical Imaging, Inc.

8 FDA decisions under this applicant name. See the company

  • K100102CS-Series-FPOmega Medical Imaging, Inc. · 2010
  • K093572R650 Qdasm CollimatorOmega Medical Imaging, Inc. · 2010
  • K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc. · 2007
  • K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc. · 2006
  • K050092R605 Facs CollimeterOmega Medical Imaging, Inc. · 2005

Recent decisions in JAA

The JAA category page

  • K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation · 2026
  • K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025
  • K242488Soteria E-ViewOmega Medical Imaging, LLC · 2025
  • K242948Adora DRFi (04550010)Nrt X-Ray A/S · 2024
  • K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America · 2024

https://510kreport.com/device/K990055 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990055: B-400 Ceiling Mounted Possitioner, Model B-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990055

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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