Cleared Traditional

K834288 - DIGITILT LS-30 REMOTE CONTROL

K834288 is the FDA 510(k) clearance for DIGITILT LS-30 REMOTE CONTROL by Elscint, Inc.. It is a Class 2 Radiology device (product code IZF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K834288 · Elscint, Inc. · Radiology device
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Dec 1983
Decision
31d
Days
Class 2
Risk

K834288 is an FDA 510(k) clearance for the DIGITILT LS-30 REMOTE CONTROL. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Elscint, Inc. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Elscint, Inc. devices

Submission Details

510(k) Number K834288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date December 29, 1983
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 - IZF System, X-ray, Tomographic

All 25
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K834288.
PHILIPS INTEGRIS H/HM SYSTEM
K925302 · Philips Medical Systems, Inc. · Dec 1992
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351 · Philips Medical Systems North America, Inc. · Jun 1989
ORALIX PANORAMIC D.C.
K852768 · Philips Medical Systems, Inc. · Sep 1985
SOMATOM 2N
K811302 · Siemens Corp. · Jun 1981
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
ZONOGRAPH 6
K810307 · Siemens Corp. · Mar 1981