Cleared Traditional

K883324 - DIGICAM LHP (DIGITAL LASER HIGH PERFORM...

K883324 is an FDA 510(k) clearance for DIGICAM LHP (DIGITAL LASER HIGH PERFORM..., manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 206-day FDA review.

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

FDA 510(k) Submission Details - K883324

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
Combination Product No
PCCP Authorized No
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.

LMC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 37
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K883324.
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K905566 · Eastman Kodak Company · Jan 1991
FUJI MEDICAL LASER IMAGER
K900885 · Fujifilm Medical System U.S.A., Inc. · Mar 1990
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · Siemens Gammasonics, Inc. · Nov 1989
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
K885127 · Fischer Imaging Corp. · Feb 1989
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
K890097 · Eastman Kodak Company · Feb 1989
FTI 200 MEDICAL THERMAL IMAGER
K882483 · Fujifilm Medical System U.S.A., Inc. · Aug 1988