Cleared Traditional

K964834 - ISOCAM II (DUAL HEAD GAMMA CAMERA)

K964834 is an FDA 510(k) clearance for ISOCAM II (DUAL HEAD GAMMA CAMERA), manufactured by Park Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K964834 · Park Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
88d
Days
Class 2
Risk

K964834 is an FDA 510(k) clearance for the ISOCAM II (DUAL HEAD GAMMA CAMERA). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Park Medical Systems, Inc. (Lachine Quebec, CA). The FDA issued a Cleared decision on February 28, 1997 after a review of 88 days - a notably fast clearance cycle.

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: 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 Park Medical Systems, Inc. devices

FDA 510(k) Submission Details - K964834

510(k) Number K964834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1996
Decision Date February 28, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
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 355
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K964834.
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · Park Medical Systems, Inc. · Apr 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · Siemens Corp. · Mar 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
K963273 · Smv America · Mar 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
PRISM XPVT SYSTEM (210823)
K964712 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
PROTEC (1024)
K963730 · Proportional Technologies, Inc. · Feb 1997