CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS— 510(k) K991535

Name: FDA 510(k) clearance K991535
Creator: U.S. Food and Drug Administration
Published: 1999-07-30

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K991535 for CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS, Substantially Equivalent on 1999-07-30. Applicant: Hitachi Medical Corp. of America. Device class: 2.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1999-05-03
Decision date: 1999-07-30
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 Hitachi Medical Corp. of America

view all

K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER2000-03-29
K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS1999-06-18
K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL1999-05-13
K981434 — EUP-OL334 LAPARASCOPICPROBE1998-07-27
K954220 — EUB-80001997-05-07

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