510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QXZClass II

Adjunctive Epicardial Vascular Physiologic Status Indicator

21 CFR 870.2200 / Cardiovascular
FDA source (opens on fda.gov)

QXZ is the FDA product code for Adjunctive Epicardial Vascular Physiologic Status Indicator, a class II device type, regulated under 21 CFR 870.2200. FDA's definition for this code reads: "The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXZ
Device name
Adjunctive Epicardial Vascular Physiologic Status Indicator
FDA definition
The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXZ

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

Applicants with the most clearances

Product code QXZ
Applicants holding the most 510(k) clearances under product code QXZ
ApplicantClearances
Cleerly, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code