VISION (NUCLEAR MEDICINE COMPUTER)— 510(k) K912573

Name: FDA 510(k) clearance K912573
Creator: U.S. Food and Drug Administration
Published: 1991-10-28

Substantially Equivalent

Summit Nuclear

FDA 510(k) clearance K912573 for VISION (NUCLEAR MEDICINE COMPUTER), Substantially Equivalent on 1991-10-28. Applicant: Summit Nuclear. Device class: 2.

Clearance details

Applicant: Summit Nuclear
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1991-06-11
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

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 Summit Nuclear

view all

K935273 — VISION FX 40 & 80 SERIES GAMMA CAMERA1994-04-18
K935318 — SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS1994-02-25
K922427 — SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM1992-09-29
K922426 — SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM1992-09-28
K920958 — SUMMIT NUCLEAR VISION NEUROSPECT1992-08-07

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