Cleared Traditional

K781983 - EXPLORAMAT

K781983 is the FDA 510(k) clearance for EXPLORAMAT by Siemens Corp.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K781983 · Siemens Corp. · Radiology device
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Dec 1978
Decision
10d
Days
Class 2
Risk

K781983 is an FDA 510(k) clearance for the EXPLORAMAT, COSMIC 2. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 10 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 Corp. devices

Submission Details

510(k) Number K781983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1978
Decision Date December 04, 1978
Days to Decision 10 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
97d faster than avg
Panel avg: 107d · This submission: 10d
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 178
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K781983.
POSI-TOT
K790685 · Victoreen, Inc. · Apr 1979
BUCKYMAT
K790069 · Siemens Corp. · Jan 1979
SIREGRAPH B-150
K790070 · Siemens Corp. · Jan 1979
SIREMAT
K781613 · Siemens Corp. · Oct 1978
BUCKY WALL STAND
K781473 · Philips Medical Systems (Cleveland), Inc. · Sep 1978
C-ARM X-RAY SYSTEM
K771051 · General Electric Co. · Jun 1977