Cleared Traditional

K812721 - DIGITRON

K812721 is the FDA 510(k) clearance for DIGITRON by Siemens Corp.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K812721 · Siemens Corp. · Radiology device
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Nov 1981
Decision
37d
Days
Class 2
Risk

K812721 is an FDA 510(k) clearance for the DIGITRON. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on November 4, 1981 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Corp. devices

Submission Details

510(k) Number K812721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1981
Decision Date November 04, 1981
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 101
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K812721.
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
K883072 · Siemens Gammasonics, Inc. · Sep 1988
ISOREX LS-36
K834496 · Elscint, Inc. · Feb 1984
OMEGA II ANGIOGRAPHIC TABLE
K812913 · General Electric Co. · Nov 1981
PANDOROS 1200A
K811149 · Siemens Corp. · Jun 1981
PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION
K810183 · Philips Medical Systems (Cleveland), Inc. · Feb 1981
ANGIOSKIP
K781991 · Siemens Corp. · Dec 1978