CRC PC Smart Chamber K1
510(k) K192199
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192199 | Date12 Sep 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPT
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1360
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The CRC-PC Smart Chamber K1 is a Radionuclide Dose Calibrator (Product Code: KPT), designed for precise measurement of radioactive dose rates in radiology settings. Classified as a Class II medical device under FDA regulations, it incorporates a well-type ionization chamber to accurately quantify radionuclide emissions, ensuring compliance with dose calibration standards for nuclear medicine and diagnostic procedures.
This device is supplied as a reusable, non-sterile instrument intended for use in controlled environments such as radiology departments or nuclear medicine labs. It operates via a web-based interface for data acquisition and analysis, with no MRI compatibility specified. Storage requires protection from electromagnetic interference and physical damage, adhering to manufacturer guidelines for optimal performance. Its FDA 510(k) clearance (K192199) confirms regulatory compliance for dose calibration applications in radiology.
Other devices from Capintec, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of environments is the CRC PC Smart Chamber K1 intended for use in and why?
The CRC PC Smart Chamber K1 is designed for controlled settings like radiology departments or nuclear medicine labs. This is because it measures radioactive dose rates, which require environments where radiation safety protocols are strictly followed to ensure accurate calibration and prevent exposure risks.
How is the CRC PC Smart Chamber K1 supplied, and what does that mean for its maintenance?
The device is supplied as a reusable, non-sterile instrument. This means it is built for repeated use in a clinical setting but does not require sterile handling. Maintenance involves following manufacturer guidelines to protect it from electromagnetic interference and physical damage, ensuring long-term accuracy and compliance with calibration standards.
Can this device be used in an MRI environment, and if not, why?
No, the CRC PC Smart Chamber K1 is not MRI-compatible. This is explicitly stated in the device description, meaning it should not be used near MRI machines due to potential interference with electromagnetic fields, which could compromise its performance or safety.
What regulatory pathway did the CRC PC Smart Chamber K1 follow to gain market authorization, and what does that imply for its use?
The device received FDA clearance through a 510(k) submission (K192199), classified as substantially equivalent under the Radiology advisory committee (RA). This implies it meets FDA standards for radionuclide dose calibration in radiology, ensuring its safety and effectiveness for measuring radioactive dose rates in clinical settings as intended.
What storage conditions are recommended for the CRC PC Smart Chamber K1, and why are they important?
The device requires storage that protects it from electromagnetic interference and physical damage. These conditions are critical because the CRC PC Smart Chamber K1 relies on precise ionization chamber measurements, which could be compromised by external electromagnetic fields or mechanical stress, leading to inaccurate dose calibration results.