Cleared Traditional

K900681 - PANORAMIC MODEL X-CALIBER X-RAY

K900681 is an FDA 510(k) clearance for PANORAMIC MODEL X-CALIBER X-RAY, manufactured by Belmont Equipment Corp.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K900681 · Belmont Equipment Corp. · Radiology device
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May 1990
Decision
100d
Days
Class 2
Risk

K900681 is an FDA 510(k) clearance for the PANORAMIC MODEL X-CALIBER X-RAY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on May 23, 1990 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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.

FDA 510(k) Submission Details - K900681

510(k) Number K900681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1990
Decision Date May 23, 1990
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 32
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K900681.
INTREX INTERORAL DENTAL X-RAY UNIT
K930925 · Keystone X-Ray, Inc. · Jul 1993
IMAGE-X 70 INTRAORAL X-RAY SYSTEM
K930761 · Afp Imaging Corp. · May 1993
HEALTHPAK X-RAY SOX BARRIERS
K923307 · Healthpak, Inc. · Jan 1993
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
K896024 · Mdt Diagnostic Co. · Jan 1990
TRIMODE SP DENTAL INTRA ORAL X-RAY
K896963 · Tempo Technology, Inc. · Jan 1990
VARIABLE KV INTREX VSK 60 - 90 KVP
K883354 · Keystone X-Ray, Inc. · Dec 1988
K900681 · PANORAMIC MODEL X-CALIBER X-RAY
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