1.5` Focal Spot Resolution Pattern

FDA 510(k) K810254 · Machlett Laboratories, Inc.

Substantially Equivalent

510(k) numberK810254

Submission

Device name
1.5` Focal Spot Resolution Pattern
Applicant
Machlett Laboratories, Inc.
Mchenry, IL, US
Received
January 30, 1981
Decision date
February 19, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXF – Test-Pattern, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1940
Specialty
Radiology

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Questions and answers

When was 1.5` Focal Spot Resolution Pattern cleared by the FDA?

1.5` Focal Spot Resolution Pattern (K810254) received a 510(k) decision of Substantially Equivalent on February 19, 1981, 20 days after the submission was received.

What is the product code of K810254?

The FDA product code is IXF – Test-Pattern, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1940.