Cleared Traditional

K972968 - ROTOGRAPH PLUS

K972968 is an FDA 510(k) clearance for ROTOGRAPH PLUS, manufactured by Chicago X-Ray Systems, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K972968 · Chicago X-Ray Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
58d
Days
Class 2
Risk

K972968 is an FDA 510(k) clearance for the ROTOGRAPH PLUS. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Chicago X-Ray Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 58 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 Chicago X-Ray Systems, Inc. devices

FDA 510(k) Submission Details - K972968

510(k) Number K972968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date October 08, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
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 103
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K972968.
SANKO INTRAORAL DENTAL X-RAY
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K973642 · Instrumentarium Imaging, Inc. · Nov 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · Eastman Kodak Company · Nov 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · Siemens AG · Sep 1997
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K972249 · Pelton & Crane Co. · Sep 1997
SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
K972168 · Pelton & Crane Co. · Sep 1997