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FDA 510(k)

SHIMADZU LATERAL C-ARM MH-31

K-Number: K882311 · 1988-09-14

ApplicantShimadzu Precision Instruments, Inc.
Decision Date1988-09-14
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU LATERAL C-ARM MH-31 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Precision Instruments, Inc.. It received FDA 510(k) clearance on 1988-09-14 under 510(k) number K882311. 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 SHIMADZU LATERAL C-ARM MH-31?

SHIMADZU LATERAL C-ARM MH-31 is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is Shimadzu Precision Instruments, Inc.. The 510(k) number is K882311.

When did SHIMADZU LATERAL C-ARM MH-31 receive FDA 510(k) clearance?

SHIMADZU LATERAL C-ARM MH-31 received FDA 510(k) clearance on 1988-09-14, under 510(k) number K882311.

Who is the listed applicant for SHIMADZU LATERAL C-ARM MH-31?

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

What is the FDA product code for SHIMADZU LATERAL C-ARM MH-31?

The FDA product code for SHIMADZU LATERAL C-ARM MH-31 is JAA.

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Other records listing Shimadzu Precision Instruments, Inc. as applicant

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K940294SHIMADZU MOBILE X-RAY SYSTEMSK890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENTK884598SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200K884477SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150BK875378SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSIONK881674SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC

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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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