FLUOROSCOPE, C-ARM— 510(k) K770333

Name: FDA 510(k) clearance K770333
Creator: U.S. Food and Drug Administration
Published: 1977-03-01

Substantially Equivalent

Litton Medical Systems

FDA 510(k) clearance K770333 for FLUOROSCOPE, C-ARM, Substantially Equivalent on 1977-03-01. Applicant: Litton Medical Systems. Device class: 2.

Clearance details

Applicant: Litton Medical Systems
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1977-02-18
Decision date: 1977-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Litton Medical Systems

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K770334 — TILTING X-RAY TABLE1977-03-01
K770336 — X-RAY TUBE, ROTATING ANODE1977-03-01
K770337 — FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.1977-03-01
K770338 — X-RAY CONTROL & X-RAY HV GENERATOR1977-03-01
K770335 — COLLIMATOR, AUTOMATIC1977-02-28

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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