Cleared Traditional

K952763 - PANORAMIC X-RAY UNIT (MODIFICATION)

K952763 is an FDA 510(k) clearance for PANORAMIC X-RAY UNIT (MODIFICATION), 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 135-day FDA review.

K952763 · Planmeca Oy · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
135d
Days
Class 2
Risk

K952763 is an FDA 510(k) clearance for the PANORAMIC X-RAY UNIT (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 October 7, 1995 after a review of 135 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 - K952763

510(k) Number K952763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date October 07, 1995
Days to Decision 135 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
28d slower than avg
Panel avg: 107d · This submission: 135d
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 K952763.
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
K964659 · Dentsply Intl. · Dec 1996
TOMOGRAPH ACCESSORIES
K962120 · Steri-Oss, Inc. · Jul 1996
PROSTYLE INTRA
K955429 · Planmeca Oy · Dec 1995
PANORAMIC X-RAY UNITS, MODIFICATION
K934063 · Planmeca Oy · Dec 1993
MAMMOTEST PRODUCT, MODIFICATION
K926575 · Fischer Imaging Corp. · Mar 1993
ORTHOPHOS AND ORTHOPHOS C
K895467 · Siemens Medical Solutions USA, Inc. · Nov 1989