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)

MAX-1000A/R1

K-Number: K954590 · 1995-11-20

ApplicantToshiba America Medical Systems, In.C
Decision Date1995-11-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAX-1000A/R1 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K954590. 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 MAX-1000A/R1?

MAX-1000A/R1 is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K954590.

When did MAX-1000A/R1 receive FDA 510(k) clearance?

MAX-1000A/R1 received FDA 510(k) clearance on 1995-11-20, under 510(k) number K954590.

Who is the listed applicant for MAX-1000A/R1?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAX-1000A/R1?

The FDA product code for MAX-1000A/R1 is JAA.

Other records listing Toshiba America Medical Systems, In.C 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.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEK122842RADREX-I, SW V4.00 MODEL DRAD-3000E

View all 143 devices →

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.

↑