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)

SUNSCOPE 100

K-Number: K931941 · 1993-07-20

ApplicantSunning Corp.
Decision Date1993-07-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUNSCOPE 100 is the device name listed in this FDA 510(k) record. The listed applicant is Sunning Corp.. It received FDA 510(k) clearance on 1993-07-20 under 510(k) number K931941. 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 SUNSCOPE 100?

SUNSCOPE 100 is a medical device that received FDA 510(k) clearance on 1993-07-20. The listed applicant is Sunning Corp.. The 510(k) number is K931941.

When did SUNSCOPE 100 receive FDA 510(k) clearance?

SUNSCOPE 100 received FDA 510(k) clearance on 1993-07-20, under 510(k) number K931941.

Who is the listed applicant for SUNSCOPE 100?

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

What is the FDA product code for SUNSCOPE 100?

The FDA product code for SUNSCOPE 100 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

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.

↑