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

Ear, Nose, And Throat Image Analyzer

21 CFR 874.4775 / Ear, Nose, Throat
FDA source (opens on fda.gov)

SHL is the FDA product code for Ear, Nose, And Throat Image Analyzer, a class II device type, regulated under 21 CFR 874.4775. FDA's definition for this code reads: "An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHL
Device name
Ear, Nose, And Throat Image Analyzer
FDA definition
An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.
Regulation
21 CFR 874.4775
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SHL

By decision year
2 clearances under product code SHL with a decision year between 2026 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SHL by decision year
YearClearances
20262

Applicants with the most clearances

Product code SHL
Applicants holding the most 510(k) clearances under product code SHL
ApplicantClearances
Ironsides Medical, Inc.1
Tyto Care Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code