Cleared Traditional

K972312 - SIEMENS ORTHOPHOS DS/DS CEPH

K972312 is an FDA 510(k) clearance for SIEMENS ORTHOPHOS DS/DS CEPH, manufactured by Siemens AG. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K972312 · Siemens AG · Radiology device
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Sep 1997
Decision
87d
Days
Class 2
Risk

K972312 is an FDA 510(k) clearance for the SIEMENS ORTHOPHOS DS/DS CEPH. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Siemens AG (North Attleboro, US). The FDA issued a Cleared decision on September 15, 1997 after a review of 87 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 Siemens AG devices

FDA 510(k) Submission Details - K972312

510(k) Number K972312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date September 15, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 90
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K972312.
VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.
K974077 · J. Morita USA, Inc. · Jan 1998
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K973642 · Instrumentarium Imaging, Inc. · Nov 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · Eastman Kodak Company · Nov 1997
PM 2002 CC PROLINE
K970812 · Planmeca Oy · Aug 1997
PROSTYLE INTRA
K970975 · Planmeca Oy · Apr 1997
PM 2002 CC PROLINE
K970263 · Planmeca Oy · Feb 1997