ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)— 510(k) K970128

Name: FDA 510(k) clearance K970128
Creator: U.S. Food and Drug Administration
Published: 1997-04-11

Substantially Equivalent

Park Medical Systems, Inc.

FDA 510(k) clearance K970128 for ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA), Substantially Equivalent on 1997-04-11. Applicant: Park Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Park Medical Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1997-01-14
Decision date: 1997-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Park Medical Systems, Inc.

view all

K964834 — ISOCAM II (DUAL HEAD GAMMA CAMERA)1997-02-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.