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FDA 510(k)

SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES

K-Number: K936236 · 1995-05-11

ApplicantShimadzu Medical Systems
Decision Date1995-05-11
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K936236. 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 IMAGE AMPLIFIER IA-12LM SERIES?

SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K936236.

When did SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES receive FDA 510(k) clearance?

SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES received FDA 510(k) clearance on 1995-05-11, under 510(k) number K936236.

Who is the listed applicant for SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES?

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

What is the FDA product code for SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES?

The FDA product code for SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES is JAA.

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Other records listing Shimadzu 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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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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