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

Spinal Imaging System For Neuraxial Procedures

21 CFR 868.1985 / Anesthesiology
FDA source (opens on fda.gov)

QXD is the FDA product code for Spinal Imaging System For Neuraxial Procedures, a class II device type, regulated under 21 CFR 868.1985. FDA's definition for this code reads: "A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXD
Device name
Spinal Imaging System For Neuraxial Procedures
FDA definition
A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures.
Regulation
21 CFR 868.1985
Device class
Class II
Review panel
Anesthesiology
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 QXD

By decision year
1 clearance under product code QXD with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXD by decision year
YearClearances
20241

Applicants with the most clearances

Product code QXD
Applicants holding the most 510(k) clearances under product code QXD
ApplicantClearances
Intuitap Medical, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code