510(k) Report

510(k) · Cleared

Cleared

Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm

K880527510(k) TraditionalCleared Feb 29, 198820-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

Fischer Imaging Corp. · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on Feb 29, 1988 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 29, 1988
Review
20 days
Class
Class II
Product code
JAA
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK880527 Ceiling Mounted Fluoroscopic C-Arm Ariel C-ArmFischer Imaging Corp. · 1988
  2. Descendant · cites it directly · 0 of its ownK990055 B-400 Ceiling Mounted Possitioner, Model B-400Omega Medical Imaging, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K990055B-400 Ceiling Mounted Possitioner, Model B-400Omega Medical Imaging, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K880527, 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), 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
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K990055B-400 Ceiling Mounted Possitioner, Model B-400Omega Medical Imaging, Inc.19990

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, K990055 (Omega Medical Imaging, Inc., 1999) has gone furthest, with 0 descendants of its own.

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—

More from Fischer Imaging Corp.

69 FDA decisions under this applicant name. See the company

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  • K021113MammopathFischer Imaging Corp. · 2002
  • K981414LC PositionerFischer Imaging Corp. · 1998
  • K973400Mammotest Adapter DriverFischer Imaging Corp. · 1997
  • K964806MD-1835Fischer Imaging Corp. · 1997

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https://510kreport.com/device/K880527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880527: Ceiling Mounted Fluoroscopic C-Arm Ariel C-Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880527

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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