Cleared Traditional

K972168 - SIDEXIS DIGITAL RADIOGRAPHY SYSTEM

K972168 is an FDA 510(k) clearance for SIDEXIS DIGITAL RADIOGRAPHY SYSTEM, manufactured by Pelton & Crane Co.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972168 · Pelton & Crane Co. · Radiology device
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Sep 1997
Decision
88d
Days
Class 2
Risk

K972168 is an FDA 510(k) clearance for the SIDEXIS DIGITAL RADIOGRAPHY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Pelton & Crane Co. (North Attleboro, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Pelton & Crane Co. devices

FDA 510(k) Submission Details - K972168

510(k) Number K972168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date September 05, 1997
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 143
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