Cleared Special

WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION (K991626) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K991626 · Analogic Corp. · Radiology device

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Jul 1999

Decision

52d

Days

Class 2

Risk

K991626 is an FDA 510(k) clearance for the WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION. 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 Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on July 2, 1999 after a review of 52 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Analogic Corp. devices

Submission Details

510(k) Number	K991626 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 11, 1999
Decision Date	July 02, 1999
Days to Decision	52 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

55d faster than avg

Panel avg: 107d · This submission: 52d

Pathway characteristics

Modification to existing cleared device.

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 751

Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K991626.

SYNGO MULTIMODALITY WORKSTATION

K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001

ODYSSEY LX, MODEL 211320

K003437 · Philips Medical Systems (Cleveland), Inc. · Feb 2001

AX WORKSTATION

K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999

ADVANTAGE WINDOWS (AW) FUSION

K983256 · GE Medical Systems · Dec 1998

PLATINUM READING, REVIEW & ANALYSIS WORKSTATION

K981217 · GE Medical Systems · Jun 1998

KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER

K980118 · Eastman Kodak Company · Mar 1998

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K991626

Analogic Corp.

Peabody, MA · US

GARET VAN GENNEP

Regulatory profile

32 submissions 32 cleared

100% clearance rate · Active in Radiology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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