Video Annotator Model PK2310
510(k) K910384
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910384 | Date16 Apr 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JAA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Video Annotator Model PK2310 is a System, X-Ray, Fluoroscopic, Image-Intensified device, classified under the Radiology medical specialty. It is designed to enhance fluoroscopic imaging by annotating video outputs, facilitating real-time marking or labeling of anatomical features or procedural steps during radiographic procedures. This device integrates with fluoroscopy systems to provide visual annotations directly on the displayed image, improving diagnostic clarity and procedural guidance for radiologists and interventionalists.
This device is intended for use in radiology settings, where fluoroscopic imaging is performed. It is not described as single-use or reusable in the regulatory data, though its intended use in clinical environments suggests it may require periodic maintenance or calibration. The device is not explicitly labeled as MRI-safe or unsafe in the provided specifications. The model number PK2310 is the unique identifier for this product, and it was cleared under FDA 510(k) K910384 in 1991. No details regarding sterility or storage conditions are provided in the available data.
Other devices from Perkins Mfg. Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Video Annotator Model PK2310 used for?
The Video Annotator Model PK2310 is designed to enhance fluoroscopic imaging by annotating video outputs in real time. It allows radiologists and interventionalists to mark or label anatomical features or procedural steps directly on the displayed fluoroscopic image, improving diagnostic accuracy and procedural guidance during radiographic procedures.
How is the Video Annotator Model PK2310 supplied and maintained?
The regulatory data does not specify whether the Video Annotator Model PK2310 is single-use or reusable. However, given its clinical use in radiology settings, it likely requires periodic maintenance or calibration to ensure accurate and reliable performance. The manufacturer, Perkins Mfg. Co., would provide specific guidelines for supply and maintenance.
Is the Video Annotator Model PK2310 sterile, and what are the storage requirements?
The provided data does not include details regarding the sterility of the Video Annotator Model PK2310 or specific storage conditions. For proper use, clinicians should refer to the manufacturer’s instructions, which would outline any necessary precautions for handling, storage, and environmental requirements to maintain device functionality.
What regulatory approval does the Video Annotator Model PK2310 hold?
The Video Annotator Model PK2310 was cleared under the FDA’s 510(k) program with the clearance number K910384, dated April 16, 1991. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device at the time of submission.
Can the Video Annotator Model PK2310 be used with any fluoroscopy system?
The Video Annotator Model PK2310 is intended to integrate with fluoroscopy systems to provide annotation capabilities. While the device is designed for compatibility with fluoroscopic imaging systems, specific integration requirements or compatibility details would be outlined in the manufacturer’s instructions for use. Clinicians should verify compatibility with their existing equipment before implementation.