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FDA 510(k)

STS(TM) FLUOROSCOPIC IMAGING MODULE

K-Number: K905278 · 1991-02-04

ApplicantMedstone Intl., Inc.
Decision Date1991-02-04
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STS(TM) FLUOROSCOPIC IMAGING MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Medstone Intl., Inc.. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K905278. 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 STS(TM) FLUOROSCOPIC IMAGING MODULE?

STS(TM) FLUOROSCOPIC IMAGING MODULE is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Medstone Intl., Inc.. The 510(k) number is K905278.

When did STS(TM) FLUOROSCOPIC IMAGING MODULE receive FDA 510(k) clearance?

STS(TM) FLUOROSCOPIC IMAGING MODULE received FDA 510(k) clearance on 1991-02-04, under 510(k) number K905278.

Who is the listed applicant for STS(TM) FLUOROSCOPIC IMAGING MODULE?

The FDA 510(k) record lists Medstone Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STS(TM) FLUOROSCOPIC IMAGING MODULE?

The FDA product code for STS(TM) FLUOROSCOPIC IMAGING MODULE 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.

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Other records listing Medstone Intl., Inc. 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.

K013620MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTIONK010900STS-T LITHOTRIPTER, MODEL STS-T

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.

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