Cleared Traditional

K881017 - DPS-33

K881017 is the FDA 510(k) clearance for DPS-33 by Adac Laboratories. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K881017 · Adac Laboratories · Radiology device
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Aug 1988
Decision
154d
Days
Class 2
Risk

K881017 is an FDA 510(k) clearance for the DPS-33,000 WITH CENTOR OPTION. 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 Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on August 11, 1988 after a review of 154 days - an extended review 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 Adac Laboratories devices

Submission Details

510(k) Number K881017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date August 11, 1988
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K881017.
DIGITRON 3, LV ANALYSIS PROTCOL
K885318 · Siemens Gammasonics, Inc. · Feb 1989
MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
K883604 · Medrad, Inc. · Nov 1988
DIGITRON STENOSIS PROTOCOL
K881481 · Siemens Gammasonics, Inc. · Oct 1988
VIEWPOINT
K882205 · Adac Laboratories · Aug 1988
DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM
K872455 · Adac Laboratories · Sep 1987
POLYTRON MODELS 1001, 1002 AND 1004
K870821 · Siemens Medical Solutions USA, Inc. · Jul 1987