Cleared Traditional

K834611 - SINGUL-XR RP NON SCREEN MED. FILM

K834611 is an FDA 510(k) clearance for SINGUL-XR RP NON SCREEN MED. FILM, manufactured by Cea America Corp.. The device is a Class 1 Radiology device with product code IWZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K834611 · Cea America Corp. · Radiology device
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Feb 1984
Decision
63d
Days
Class 1
Risk

K834611 is an FDA 510(k) clearance for the SINGUL-XR RP NON SCREEN MED. FILM. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Cea America Corp. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - the FDA radiology and imaging software oversight framework. 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 Cea America Corp. devices

FDA 510(k) Submission Details - K834611

510(k) Number K834611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date February 21, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

IWZ Device Classification - Class 1, General Controls

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWZ Film, Radiographic

All 21
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K834611.
3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
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KODAK T-MAT L FILM SO-387
K833234 · Eastman Kodak Company · Oct 1983
CRONEX LO-DOSE MAMMOGRAPHY
K832504 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
KODAK CINEFLUOROGRAPHIC FILM SO-274
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