Identifiers
- 510(k) Number
- K222195 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 aprevo Digital Workflow is a radiology device that has been determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process. It is identified by the device name aprevo® Digital Workflow and product code LLZ.
The device was manufactured by Carlsmed, Inc. located at 1800 Aston Ave. Suite 100, Carlsbad, CA 92008, United States. It received FDA 510(k) clearance under K222195 on December 30, 2022, following submission on July 22, 2022, and is not designated as a third-party review device.
Frequently asked questions
What is the aprevo® Digital Workflow used for?
The aprevo® Digital Workflow is a radiology device, as indicated by its product code LLZ and advisory committee classification RA, which corresponds to radiology. It is intended for use in radiological applications, though specific clinical indications are not detailed in the provided data beyond its classification as a radiology device.
How was the aprevo® Digital Workflow cleared for market?
The aprevo® Digital Workflow received FDA 510(k) clearance through a traditional submission process, identified by K-number K222195. It was determined to be substantially equivalent to a predicate device, with clearance granted on December 30, 2022, following a submission received on July 22, 2022. It was not reviewed by a third party.
Who manufactures the aprevo® Digital Workflow and where is it made?
The aprevo® Digital Workflow is manufactured by Carlsmed, Inc., located at 1800 Aston Ave., Suite 100, Carlsbad, CA 92008, United States. This information is explicitly stated in the device data under manufacturer and address details.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222195 | Class II | Active |
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Manufacturer
- Manufacturer
- Carlsmed, Inc.
Sources (1)
- FDA 510(k) K222195 24 fields · synced Sep 23, 2026