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FDA 510(k)

MOBILE X-RAY TELEVISION UNIT WHA-10A/B

K-Number: K895394 · 1989-11-13

ApplicantShimadzu Corp.
Decision Date1989-11-13
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILE X-RAY TELEVISION UNIT WHA-10A/B is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K895394. 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 MOBILE X-RAY TELEVISION UNIT WHA-10A/B?

MOBILE X-RAY TELEVISION UNIT WHA-10A/B is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Shimadzu Corp.. The 510(k) number is K895394.

When did MOBILE X-RAY TELEVISION UNIT WHA-10A/B receive FDA 510(k) clearance?

MOBILE X-RAY TELEVISION UNIT WHA-10A/B received FDA 510(k) clearance on 1989-11-13, under 510(k) number K895394.

Who is the listed applicant for MOBILE X-RAY TELEVISION UNIT WHA-10A/B?

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

What is the FDA product code for MOBILE X-RAY TELEVISION UNIT WHA-10A/B?

The FDA product code for MOBILE X-RAY TELEVISION UNIT WHA-10A/B is JAA.

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Other records listing Shimadzu Corp. 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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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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