Mammographic Model CXR 51 MO-6'/0.6 SH

FDA 510(k) K864042 · Absolute X-Ray Corp.

Substantially Equivalent

510(k) numberK864042

Submission

Device name
Mammographic Model CXR 51 MO-6'/0.6 SH
Applicant
Absolute X-Ray Corp.
Long Island City, NY, US
Received
October 16, 1986
Decision date
October 27, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ITY – Assembly, Tube Housing, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1760
Specialty
Radiology

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Questions and answers

When was Mammographic Model CXR 51 MO-6'/0.6 SH cleared by the FDA?

Mammographic Model CXR 51 MO-6'/0.6 SH (K864042) received a 510(k) decision of Substantially Equivalent on October 27, 1986, 11 days after the submission was received.

What is the product code of K864042?

The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.