DeviceClearance

Product code DQK— Cardiovascular

AcQMap High Resolution Imaging and Mapping System

Classification name
Computer, Diagnostic, Programmable
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Total cleared
437
First cleared
Most recent

Market context for product code DQK

FDA has cleared 437 devices under product code DQK between 1976 and 2026, filed by 192 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DQK

Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DQK

1–100 of 437

Data sourced from openFDA. This site is unofficial and independent of the FDA.