Cleared Traditional

K884621 - DIGISCAN

K884621 is the FDA 510(k) clearance for DIGISCAN by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K884621 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
173d
Days
Class 2
Risk

K884621 is an FDA 510(k) clearance for the DIGISCAN. 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 Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 173 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K884621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date April 26, 1989
Days to Decision 173 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
66d slower than avg
Panel avg: 107d · This submission: 173d
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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K884621.
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
K900586 · Medrad, Inc. · Feb 1990
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · Fujifilm Medical System U.S.A., Inc. · Dec 1989
14 COLOR VIDEO DISPLAY 211-260-010
K893585 · Mennen Medical, Inc. · Jul 1989
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K884995 · Siemens Gammasonics, Inc. · Feb 1989
DIGITRON 3, LV ANALYSIS PROTCOL
K885318 · Siemens Gammasonics, Inc. · Feb 1989
MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
K883604 · Medrad, Inc. · Nov 1988