Identity
- Trade Name
- Flourocsan InSight FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- The Fluoroscan InSight FD System 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. FDA UDI
- Model / Reference
- InSight FD FDA UDI
- Description
- The Fluoroscan InSight FD System 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. FDA UDI
Identifiers
- Catalog Number
- Insight-FD FDA UDI
- Primary DI / UDI-DI
- 15420045505773 FDA UDI
- FDA Product Code
- OXO FDA UDI
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable general-purpose fluoroscopic x-ray system, digital
Flourocsan InSight by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable general-purpose fluoroscopic x-ray system, digital.
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- Cios Alpha — Siemens Healthcare · Class II
- O-ARM® — MEDTRONIC NAVIGATION, INC. · Class II
- O-ARM® — MEDTRONIC NAVIGATION, INC. · Class II
- O-ARM® — MEDTRONIC NAVIGATION, INC. · Class II
- O-arm O2 — MEDTRONIC NAVIGATION, INC. · Class II
- TAU Model 1000-0015 Mini C-Arm — Ziehm-Orthoscan, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 4f3223d9-76ab-4528-a2a5-668092ee3ea7 36 fields · synced May 30, 2026