FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM— 510(k) K051025

Clearance details

Applicant

Hologic, Inc.

Product code

Code JAA

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2005-04-22

Decision date

2005-05-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Bedford, MA, US

• K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
• K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
• K242488 — Soteria E-View2025-01-06
• K242948 — Adora DRFi (04550010)2024-12-23
• K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

• K254090 — I-View®2026-09-02
• K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
• K253634 — CoolSeal Generator® (CSL-200-90)2026-06-17
• K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25
• K243341 — Genius AI Detection 2.02025-07-31

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1326-2013 — Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.Class II·Terminated·Hologic, Inc.·20130425
• Z-1327-2013 — Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.Class II·Terminated·Hologic, Inc.·20130425
• Z-2452-2012 — Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device 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 procedures, and light anatomy imaging situation.Class II·Terminated·Hologic, Inc.·20120914
• Z-2453-2012 — Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device 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 procedures, and light anatomy imaging situation.Class II·Terminated·Hologic, Inc.·20120914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051025.