Cleared Traditional

K811196 - ALLMEC 90/15

K811196 is an FDA 510(k) clearance for ALLMEC 90/15, manufactured by Tecnomed, Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K811196 · Tecnomed, Inc. · Radiology device
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Jun 1981
Decision
40d
Days
Class 2
Risk

K811196 is an FDA 510(k) clearance for the ALLMEC 90/15. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Tecnomed, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Tecnomed, Inc. devices

FDA 510(k) Submission Details - K811196

510(k) Number K811196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1981
Decision Date June 09, 1981
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXJ Device Classification - Class 2, Special Controls

Product Code KXJ Table, Radiologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - KXJ Table, Radiologic

All 14
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K811196.
MEDEX X-RAY TABLE
K854328 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
SIEMENS SIRESKOP 4
K820111 · Siemens Corp. · Feb 1982
DUAL PEDESTAL TABLE
K811969 · Philips Medical Systems (Cleveland), Inc. · Aug 1981
TILTING IMAGING TABLE #846T
K803120 · Quinton, Inc. · Jan 1981
KOORDINAT 3D
K790783 · Siemens Corp. · May 1979
KOORDINAT ANGIO
K781992 · Siemens Corp. · Dec 1978