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

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

21 CFR 892.2060 / Radiology
FDA source (opens on fda.gov)

POK is the FDA product code for Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a class II device type, regulated under 21 CFR 892.2060. FDA's definition for this code reads: "Assist users in characterizing lesions identified on acquired medical images". As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
POK
Device name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
FDA definition
Assist users in characterizing lesions identified on acquired medical images
Regulation
21 CFR 892.2060
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
23
Ingested recalls
0

Clearances, product code POK

By decision year
23 clearances under product code POK with a decision year between 2017 and 2026, 2024 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code POK by decision year
YearClearances
20171
20191
20202
20212
20221
20231
20246
20255
20264

Applicants with the most clearances

Product code POK
Applicants holding the most 510(k) clearances under product code POK
ApplicantClearances
Koios Medical, Inc.4
Brightheart3
Brainomix Limited2
Ischemaview, Inc.2
Sonio2
Aisap1
Avenda Health Inc.1
Avicenna.ai1
Circle Cardiovascular Imaging Inc1
Echo IQ, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order