Cleared Traditional

K982824 - X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID

K982824 is an FDA 510(k) clearance for X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881..., manufactured by I.E.D., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K982824 · I.E.D., Inc. · Radiology device
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Oct 1998
Decision
79d
Days
Class 2
Risk

K982824 is an FDA 510(k) clearance for the X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by I.E.D., Inc. (Islandia, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 I.E.D., Inc. devices

FDA 510(k) Submission Details - K982824

510(k) Number K982824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date October 29, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 219
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K982824.
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K981657 · Philips Medical Systems North America, Inc. · Jun 1998