Cleared Traditional

K883324 - DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883324 · Siemens Gammasonics, Inc. · Radiology device
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Feb 1989
Decision
206d
Days
Class 2
Risk

K883324 is an FDA 510(k) clearance for the DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE). Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Des Plaines, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Siemens Gammasonics, Inc. devices

Submission Details

510(k) Number K883324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1988
Decision Date February 27, 1989
Days to Decision 206 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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.