Cleared Traditional

K828575 - F-100 FLUOROSCOPIC CONTROL AND XF-100 HIGH VOLTAGE GENERATOR (FDA 510(k) Clearance)

K828575 · Interchange Manufacturer Corp. · Radiology device
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Jan 1983
Decision
60d
Days
-
Risk

K828575 is an FDA 510(k) clearance for the F-100 FLUOROSCOPIC CONTROL AND XF-100 HIGH VOLTAGE GENERATOR.

Submitted by Interchange Manufacturer Corp. (Houston, US). The FDA issued a Cleared decision on January 3, 1983 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interchange Manufacturer Corp. devices

Submission Details

510(k) Number K828575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1982
Decision Date January 03, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -