Cleared Traditional

K933446 - PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)

K933446 is an FDA 510(k) clearance for PICTURE ARCHIVING & COMMUNICATIONS SYST..., manufactured by Sudbury Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K933446 · Sudbury Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
111d
Days
Class 2
Risk

K933446 is an FDA 510(k) clearance for the PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Sudbury Systems, Inc. (Sudbury, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sudbury Systems, Inc. devices

FDA 510(k) Submission Details - K933446

510(k) Number K933446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date November 01, 1993
Days to Decision 111 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 393
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K933446.
QUANTITATIVE HEART
K940236 · Siemens Medical Solutions USA, Inc. · May 1994
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
ECAT PRT
K940478 · Cti Pet Systems, Inc. · Mar 1994
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
K932745 · Adac Laboratories · Aug 1993
GCA-7200A
K931297 · Toshiba America Medical Systems, In.C · Jul 1993
CORT-EX
K926133 · General Electric Co. · Jun 1993