Cleared Traditional

K912341 - MULTICAM I 8X10

K912341 is an FDA 510(k) clearance for MULTICAM I 8X10, manufactured by Camtronics, Ltd.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K912341 · Camtronics, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
94d
Days
Class 2
Risk

K912341 is an FDA 510(k) clearance for the MULTICAM I 8X10. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Camtronics, Ltd. (Hartland, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Camtronics, Ltd. devices

FDA 510(k) Submission Details - K912341

510(k) Number K912341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1991
Decision Date August 26, 1991
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 158
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K912341.
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · Fischer Imaging Corp. · Jan 1992
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694 · Fischer Imaging Corp. · Nov 1991
FLUROSPOT H VERSION 2
K914525 · Siemens Medical Solutions USA, Inc. · Nov 1991
PHILIPS DIAGNOST 96
K912470 · Philips Medical Systems, Inc. · Aug 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · Siemens Medical Solutions USA, Inc. · Jul 1991
PHILIPS INTEGRIS I 2000 SYSTEM
K904012 · Philips Medical Systems, Inc. · Nov 1990