510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QVAClass II

Fludeoxyglucose F18-Guided Radiation Therapy System

21 CFR 892.5060 / Radiology
FDA source (opens on fda.gov)

QVA is the FDA product code for Fludeoxyglucose F18-Guided Radiation Therapy System, a class II device type, regulated under 21 CFR 892.5060. FDA's definition for this code reads: "A fludeoxyglucose F18-guided radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
QVA
Device name
Fludeoxyglucose F18-Guided Radiation Therapy System
FDA definition
A fludeoxyglucose F18-guided radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.
Regulation
21 CFR 892.5060
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
3

Clearances, product code QVA

By decision year
2 clearances under product code QVA with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVA by decision year
YearClearances
20231
20251

Applicants with the most clearances

Product code QVA
Applicants holding the most 510(k) clearances under product code QVA
ApplicantClearances
Reflexion Medical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code