Radiographic Ceiling Tube Support CTS15

FDA 510(k) K893653 · Fischer Imaging Corp.

Substantially Equivalent

510(k) numberK893653

Submission

Device name
Radiographic Ceiling Tube Support CTS15
Applicant
Fischer Imaging Corp.
Denver, CO, US
Received
May 15, 1989
Decision date
June 23, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYB – Tube Mount, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1770
Specialty
Radiology

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Questions and answers

When was Radiographic Ceiling Tube Support CTS15 cleared by the FDA?

Radiographic Ceiling Tube Support CTS15 (K893653) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 39 days after the submission was received.

What is the product code of K893653?

The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.