Cleared Traditional

K990383 - APOLLO 5, APOLLO 10

K990383 is an FDA 510(k) clearance for APOLLO 5, manufactured by Precitron A.B.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K990383 · Precitron A.B. · Radiology device
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May 1999
Decision
86d
Days
Class 2
Risk

K990383 is an FDA 510(k) clearance for the APOLLO 5, APOLLO 10. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Precitron A.B. (Uppsala, SE). The FDA issued a Cleared decision on May 5, 1999 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Precitron A.B. devices

FDA 510(k) Submission Details - K990383

510(k) Number K990383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date May 05, 1999
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

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