Cleared Traditional

K885318 - DIGITRON 3

K885318 is an FDA 510(k) clearance for DIGITRON 3, manufactured by Siemens Gammasonics, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K885318 · Siemens Gammasonics, Inc. · Radiology device
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Feb 1989
Decision
49d
Days
Class 2
Risk

K885318 is an FDA 510(k) clearance for the DIGITRON 3, LV ANALYSIS PROTCOL. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Siemens Gammasonics, Inc. (Des Plaines, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Siemens Gammasonics, Inc. devices

FDA 510(k) Submission Details - K885318

510(k) Number K885318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1988
Decision Date February 17, 1989
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1151
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K885318.
14 COLOR VIDEO DISPLAY 211-260-010
K893585 · Mennen Medical, Inc. · Jul 1989
DIGISCAN
K884621 · Siemens Medical Solutions USA, Inc. · Apr 1989
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K884995 · Siemens Gammasonics, Inc. · Feb 1989
MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
K883604 · Medrad, Inc. · Nov 1988
DIGITRON STENOSIS PROTOCOL
K881481 · Siemens Gammasonics, Inc. · Oct 1988
DPS-33,000 WITH CENTOR OPTION
K881017 · Adac Laboratories · Aug 1988