510(k) · Cleared

Recalled · Class II · 2013

Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System

K051025510(k) SpecialCleared May 13, 200521-day reviewClass II21 CFR 892.1650Recalls 4

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

Hologic, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on May 13, 2005 as substantially equivalent to K974058 (Hologic, Inc., 1998) after a 21-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 4 times.

Decided: May 13, 2005
Review: 21 days
Class: Class II
Product code: JAA
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K974058 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK974058 FS IV Mini C-Arm SystemHologic, Inc. · 1998
This deviceK051025 Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. · 2005
Descendant · cites it directly · 0 of its ownK120388 Insight - FD Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K120388Insight - FD Mini C-Arm Fluoroscopic Imaging SystemHologic, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974058	FS IV Mini C-Arm System	Hologic, Inc.	1998	—
0 (this device)	K051025	Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System	Hologic, Inc.	2005	—
+1	K120388	Insight - FD Mini C-Arm Fluoroscopic Imaging System	Hologic, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K051025, 1998–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K974058	FS IV Mini C-Arm System Summary page 1 …y System, 21 CFR 892.1650 F.3.3 Classification Panel: Radiology F.3.4 Product Code: 90 JAA F.3.5 Predicate Device 510(k) No.: K974058 Trade Name: FS IV Mini C- Arm System SE Date: January 12, 1998. Manufacturer: Hologic, I…	Hologic, Inc.	1998	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K120388	Insight - FD Mini C-Arm Fluoroscopic Imaging System	Hologic, Inc.	2012	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 25, 2013	Class II	Z-1327-2013	Software design	The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
Apr 25, 2013	Class II	Z-1326-2013	Software design	The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
Sep 14, 2012	Class II	Z-2452-2012	Software design	InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a…
Sep 14, 2012	Class II	Z-2453-2012	Software design	Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K120388 (Hologic, Inc., 2012) 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

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAA

89in 2024

2007high 276 (2014) · low 18 (2008)2026

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

Recalls per year · JAA

4in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	35	9,517
2008	6	18	21	9,484
2009	0	—	18	12,040
2010	1	—	6	5,803
2011	4	48	7	14,000
2012	1	—	2	11,684
2013	6	129	3	13,706
2014	6	276	1	10,265
2015	3	197	1	2,922
2016	2	—	7	35
2017	1	—	3	56
2018	3	30	1	36
2019	6	49	2	49
2020	4	39	2	39
2021	6	104	2	35
2022	1	—	5	34
2023	2	—	9	41
2024	3	89	2	25
2025	2	—	4	33
2026	1	—	0	—

What is it indicated for?

The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051025 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051025: Fluoroscan Insight Mini C-Arm Fluoroscopic 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/K051025

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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