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

Surgical Planning Software For Neurological Stereotaxic Instruments

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

QRI is the FDA product code for Surgical Planning Software For Neurological Stereotaxic Instruments, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QRI
Device name
Surgical Planning Software For Neurological Stereotaxic Instruments
FDA definition
A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
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 QRI

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

Applicants with the most clearances

Product code QRI
Applicants holding the most 510(k) clearances under product code QRI
ApplicantClearances
FHC, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code