Cleared Traditional

K800788 - SIREGRAPH C

K800788 is the FDA 510(k) clearance for SIREGRAPH C by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K800788 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 1980
Decision
36d
Days
Class 2
Risk

K800788 is an FDA 510(k) clearance for the SIREGRAPH C. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K800788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1980
Decision Date May 14, 1980
Days to Decision 36 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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 164
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K800788.
DIGITAL RADIOGRAPHY CHEST DEVICE
K803049 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
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K803130 · Siemens Corp. · Jan 1981
VERTIX 3D-U
K802200 · Siemens Corp. · Oct 1980
GENERAL ELECTRIC RADVIEW MARK I SYSTEM
K800564 · General Electric Co. · May 1980
POSI-TOT
K790685 · Victoreen, Inc. · Apr 1979
BUCKYMAT
K790069 · Siemens Corp. · Jan 1979