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

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

21 CFR 892.2090 / Radiology
FDA source (opens on fda.gov)

QDQ is the FDA product code for Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, a class II device type, regulated under 21 CFR 892.2090. FDA's definition for this code reads: "A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device...". As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDQ
Device name
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
FDA definition
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Regulation
21 CFR 892.2090
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
40
Ingested recalls
0

Clearances, product code QDQ

By decision year
40 clearances under product code QDQ with a decision year between 2018 and 2026, 2026 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code QDQ by decision year
YearClearances
20182
20192
20203
20215
20224
20232
20247
20255
202610

Applicants with the most clearances

Product code QDQ
Applicants holding the most 510(k) clearances under product code QDQ
ApplicantClearances
Screenpoint Medical7
Deephealth5
Lunit Inc.5
Therapixel5
Hologic, Inc.4
iCAD, Inc.4
See-Mode Technologies Pty Ltd2
BeamWorks, Inc.1
Median Technologies1
Quantib B.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code