Cleared Traditional

K934063 - PANORAMIC X-RAY UNITS

K934063 is an FDA 510(k) clearance for PANORAMIC X-RAY UNITS, manufactured by Planmeca Oy. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K934063 · Planmeca Oy · Radiology device
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Dec 1993
Decision
106d
Days
Class 2
Risk

K934063 is an FDA 510(k) clearance for the PANORAMIC X-RAY UNITS, MODIFICATION. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on December 15, 1993 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Planmeca Oy devices

FDA 510(k) Submission Details - K934063

510(k) Number K934063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date December 15, 1993
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 78
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K934063.
TOMOGRAPH ACCESSORIES
K962120 · Steri-Oss, Inc. · Jul 1996
PROSTYLE INTRA
K955429 · Planmeca Oy · Dec 1995
PANORAMIC X-RAY UNIT (MODIFICATION)
K952763 · Planmeca Oy · Oct 1995
MAMMOTEST PRODUCT, MODIFICATION
K926575 · Fischer Imaging Corp. · Mar 1993
ORTHOPHOS AND ORTHOPHOS C
K895467 · Siemens Medical Solutions USA, Inc. · Nov 1989
GE 900
K811103 · General Electric Co. · Jun 1981