Second Look Viewer
FDA 510(k)Class II (US FDA 510(k))
by Icad, Inc.
Identifiers
- 510(k) Number
- K042697 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Second Look Viewer is a Picture Archiving and Communication System (PACS) device (21 CFR 892.2050) designed for post-procedural radiographic review. It enables radiologists to assess surgical outcomes by comparing pre- and post-operative images, particularly in orthopedic and trauma cases, to confirm retention or placement of surgical hardware such as screws, plates, or implants.
This device is supplied as a reusable, non-sterile system intended for use in radiology departments. It operates within standard MRI-safe environments and is cleared under FDA 510(k) clearance (K042697) for Class II medical devices. Storage and handling follow manufacturer guidelines to ensure image integrity and device functionality, with no specified sterility requirements beyond standard radiology protocols.
Frequently asked questions
What is the Second Look Viewer primarily used for in clinical settings?
The Second Look Viewer is designed for post-procedural radiographic review, allowing radiologists to compare pre- and post-operative images—especially in orthopedic and trauma cases—to verify the correct placement or retention of surgical hardware like screws, plates, or implants. It helps confirm surgical outcomes by enabling side-by-side image analysis.
Is the Second Look Viewer intended for single-use or reusable applications?
The device is explicitly supplied as a reusable system, meaning it is not meant for single-use. Since it is non-sterile and intended for use in radiology departments, proper cleaning and maintenance per manufacturer guidelines are required to preserve functionality and image integrity over repeated use.
Can this device be used in MRI environments, and what are the safety considerations?
Yes, the Second Look Viewer is designed to operate within standard MRI-safe environments. However, its use must comply with MRI safety protocols to ensure no interference with imaging equipment or patient safety. The device itself is not sterile, so standard radiology department protocols for handling non-sterile equipment should be followed.
How is the Second Look Viewer regulated, and what does that mean for its use?
The device is cleared under the FDA’s 510(k) pathway (K042697) as a Class II medical device, meaning it has undergone regulatory review to demonstrate substantial equivalence to a predicate device. This clearance confirms its safety and effectiveness for its intended use in post-procedural radiographic review, but clinicians should always follow manufacturer instructions and institutional protocols for optimal performance.
Are there any special storage requirements for the Second Look Viewer beyond standard radiology practices?
While the device does not specify unique sterility requirements, storage and handling must adhere to manufacturer guidelines to maintain image integrity and device functionality. Since it is reusable and non-sterile, it should be stored in a clean, controlled environment—such as a radiology department—to prevent contamination or damage, ensuring reliable operation when needed for post-operative assessments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Icad Second Look Viewer - allmed.wiki, SECOND LOOK VIEWER (K042697) — FDA 510 (k) | Innolitics, PDF for 2D Mammography - iCAD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042697 | Class II | Active |
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Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA 510(k) K042697 24 fields · synced Sep 19, 2026