Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPACT 7600

K-Number: K950781 · 1995-06-05

ApplicantGe Dec Medical Systems
Decision Date1995-06-05
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPACT 7600 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Dec Medical Systems. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K950781. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT 7600?

COMPACT 7600 is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Ge Dec Medical Systems. The 510(k) number is K950781.

When did COMPACT 7600 receive FDA 510(k) clearance?

COMPACT 7600 received FDA 510(k) clearance on 1995-06-05, under 510(k) number K950781.

Who is the listed applicant for COMPACT 7600?

The FDA 510(k) record lists Ge Dec Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPACT 7600?

The FDA product code for COMPACT 7600 is JAA.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Dec Medical Systems as applicant

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.

K000221SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARMK993687UROVIEW 2800K992506MINI 6800 DIGITAL MOBILE C-ARMK974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)K970063SERIES 7600 MOBILE DIGITAL C-ARMK963952SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

View all 10 devices →

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.

↑