FDA 510(k)

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

K-Number: K991535 · 1999-07-30

ApplicantHitachi Medical Corp. of America

Decision Date1999-07-30

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K991535. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS?

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K991535.

When did CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS receive FDA 510(k) clearance?

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS received FDA 510(k) clearance on 1999-07-30, under 510(k) number K991535.

Who is the listed applicant for CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS?

The FDA product code for CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS is KPS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hitachi Medical Corp. of America as applicant

K994026EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER K991318CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS K991129HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL K981434EUP-OL334 LAPARASCOPICPROBE K954220EUB-8000 K962308EUB-905

View all 32 devices →

Related Devices (Code: KPS)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.