Cleared Traditional

K844298 - ADAC MODEL DPS-3300M DIGITAL PROCESSING...

K844298 is the FDA 510(k) clearance for ADAC MODEL DPS-3300M DIGITAL PROCESSING... by Adac Laboratories. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K844298 · Adac Laboratories · Radiology device
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Mar 1985
Decision
122d
Days
Class 2
Risk

K844298 is an FDA 510(k) clearance for the ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM. 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 (Sunnvale, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 122 days - within the typical 510(k) review window.

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 K844298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date March 01, 1985
Days to Decision 122 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
15d slower than avg
Panel avg: 107d · This submission: 122d
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 K844298.
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM
K855002 · Eastman Kodak Company · Apr 1986
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS
K843708 · Adac Laboratories · Apr 1985
DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER
K844037 · Toshiba Medical Systems · Mar 1985
DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER
K844783 · Adac Laboratories · Feb 1985
DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER
K844784 · Adac Laboratories · Feb 1985