Linear Scanner Probe Elscint Ltd. TL-35

FDA 510(k) K844189 · Elscint, Inc.

Substantially Equivalent

510(k) numberK844189

Submission

Device name
Linear Scanner Probe Elscint Ltd. TL-35
Applicant
Elscint, Inc.
Elk Grove Village, IL, US
Received
October 30, 1984
Decision date
February 25, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYP – Phantom, Anthropomorphic, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1370
Specialty
Radiology

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Questions and answers

When was Linear Scanner Probe Elscint Ltd. TL-35 cleared by the FDA?

Linear Scanner Probe Elscint Ltd. TL-35 (K844189) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 118 days after the submission was received.

What is the product code of K844189?

The FDA product code is IYP – Phantom, Anthropomorphic, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1370.