Cleared Traditional

K844037 - DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DI...

K844037 is an FDA 510(k) clearance for DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DI..., manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K844037 · Toshiba Medical Systems · Radiology device
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Mar 1985
Decision
136d
Days
Class 2
Risk

K844037 is an FDA 510(k) clearance for the DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER. 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 Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 136 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 Toshiba Medical Systems devices

FDA 510(k) Submission Details - K844037

510(k) Number K844037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1984
Decision Date March 01, 1985
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 K844037.
DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
K861429 · Siemens Gammasonics, Inc. · Jul 1986
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM
K855002 · Eastman Kodak Company · Apr 1986
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS
K843708 · Adac Laboratories · Apr 1985
ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM
K844298 · Adac Laboratories · 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