Pseudo-Patient
FDA 510(k)Class II (US FDA 510(k))
by Rtsafe, Inc.
Identifiers
- 510(k) Number
- K180697 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pseudo-Patient is a medical device used in the field of Radiology. It is classified as a Linear Accelerator, Medical, with a product code of IYE and a regulation number of 892.5050.
The Pseudo-Patient is supplied by Rtsafe, Inc. and has received FDA 510K clearance, with a review advisory committee of RA. The device has a unique k number, K180697, and is registered with various registration numbers, including 3013410552 and 3003768277. It is stored at an address in San Antonio, TX, with a postal code of 78231.
Frequently asked questions
What is the Pseudo-Patient used for?
The Pseudo-Patient is used in the field of Radiology as a Linear Accelerator, Medical.
Is the Pseudo-Patient supplied sterile?
The device data does not specify if the Pseudo-Patient is supplied sterile, it is recommended to consult the manufacturer for this information.
What is the regulatory status of the Pseudo-Patient?
The Pseudo-Patient has received FDA 510K clearance with a review advisory committee of RA and a regulation number of 892.5050.
How is the Pseudo-Patient stored?
The Pseudo-Patient is stored at an address in San Antonio, TX, with a postal code of 78231.
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: Pseudo-Patient (K180697) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180697 | Class II | Active |
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Manufacturer
- Manufacturer
- Rtsafe, Inc.
Sources (1)
- FDA 510(k) K180697 24 fields · synced Sep 27, 2026