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FDA 510(k)

INVENTOR RT/EXPLORER TRAUMA UNIT

K-Number: K911563 · 1991-10-23

ApplicantContinental X-Ray Corp.
Decision Date1991-10-23
Product CodeIYB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INVENTOR RT/EXPLORER TRAUMA UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Continental X-Ray Corp.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K911563. The device is classified under product code IYB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVENTOR RT/EXPLORER TRAUMA UNIT?

INVENTOR RT/EXPLORER TRAUMA UNIT is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Continental X-Ray Corp.. The 510(k) number is K911563.

When did INVENTOR RT/EXPLORER TRAUMA UNIT receive FDA 510(k) clearance?

INVENTOR RT/EXPLORER TRAUMA UNIT received FDA 510(k) clearance on 1991-10-23, under 510(k) number K911563.

Who is the listed applicant for INVENTOR RT/EXPLORER TRAUMA UNIT?

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

What is the FDA product code for INVENTOR RT/EXPLORER TRAUMA UNIT?

The FDA product code for INVENTOR RT/EXPLORER TRAUMA UNIT is IYB.

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Other records listing Continental X-Ray 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.

K972442CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002K962140ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300K961690CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105K954581ARC SERIESK950571LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270K942175LINEAR TOMOGRAPHIC SYSTEM: PMT 6000

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Related Devices (Code: IYB)

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.

K935123SUPERSTAND 300Wuestec Medical, Inc.K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000Scott Imaging Intl., Inc.K941004CTS SYSTEMAcoma Medical Imaging, Inc.K941017F/C/W TUBESTANDAcoma Medical Imaging, Inc.K940442MPR-814Xri, Inc.K935004MODEL ALPHA TS-2Dpa Consulting, Inc.

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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