Standard Imaging PT 1000 Ion Chamber
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002833 FDA 510(k)
- FDA Product Code
- KPT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1360 FDA 510(k)
- Regulation Number
- 892.1360 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Standard Imaging PT 1000 Ion Chamber is a Calibrator, Dose, Radionuclide device, classified as a Class II medical instrument. It functions as a precision measurement tool for quantifying radiation dose in radiology applications, ensuring accurate calibration of radionuclide sources and treatment planning systems. Designed for use in controlled environments, it adheres to regulatory standards for dose measurement in nuclear medicine and radiotherapy.
This device is supplied as a reusable instrument, intended for use in radiology departments and nuclear medicine facilities. It is not sterile and requires proper handling, storage, and periodic maintenance to ensure accuracy. The modification to the original PT 1000 model was cleared under FDA 510(k) K002833 in 2000, with no specific MRI safety restrictions noted. Compliance with regulatory guidelines and manufacturer instructions is essential for optimal performance and safety.
Frequently asked questions
What is the PT 1000 Ion Chamber used for?
The PT 1000 Ion Chamber is a Class II medical device designed specifically for quantifying radiation dose in radiology applications. It ensures precise calibration of radionuclide sources and treatment planning systems, which is critical for accurate dose delivery in nuclear medicine and radiotherapy. This helps maintain regulatory standards and improves patient safety by validating treatment accuracy.
Is the PT 1000 Ion Chamber reusable or single-use?
The PT 1000 Ion Chamber is supplied as a reusable instrument. It is intended for long-term use in controlled environments like radiology departments and nuclear medicine facilities, provided it undergoes proper handling, storage, and periodic maintenance to preserve its accuracy and functionality. Reusability is maintained through adherence to manufacturer guidelines and regulatory compliance.
Does the PT 1000 Ion Chamber require sterilization?
No, the PT 1000 Ion Chamber is not sterile and is not intended for sterile procedures. It is designed for use in controlled, non-sterile environments such as radiology or nuclear medicine facilities. Proper cleaning and maintenance protocols must be followed to ensure its performance and longevity, but sterilization is not part of its intended use.
What regulatory clearance does the PT 1000 Ion Chamber modification hold?
The modification to the original PT 1000 Ion Chamber was cleared under FDA 510(k) number K002833 in 2000. This clearance confirms that the modified device is substantially equivalent to legally marketed predecessors, meeting regulatory standards for dose measurement in radiology. The clearance was reviewed by the Radiology Advisory Committee under a special classification.
Are there any MRI safety restrictions for the PT 1000 Ion Chamber?
The modification to the PT 1000 Ion Chamber does not have any specific MRI safety restrictions noted in its documentation. However, since it is designed for radiation dose measurement in controlled environments like radiology or nuclear medicine, its use near MRI equipment should follow standard safety protocols to avoid interference or contamination. Always consult manufacturer guidelines for safe operation.
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: Modification to Standard Imaging Pt 1000 Ion Chamber, MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER… - FDA.report, Standard PT 1000 Ion Chamber | allmed.wiki, Standard Imaging, Inc. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002833 | Class II | Active |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (1)
- FDA 510(k) K002833 24 fields · synced Oct 1, 2026