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FDA 510(k)

INTERAD WHOLE BODY CT SCANNER

K-Number: K813162 · 1981-12-14

ApplicantInterad Systems, Inc.
Decision Date1981-12-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTERAD WHOLE BODY CT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Interad Systems, Inc.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813162. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERAD WHOLE BODY CT SCANNER?

INTERAD WHOLE BODY CT SCANNER is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Interad Systems, Inc.. The 510(k) number is K813162.

When did INTERAD WHOLE BODY CT SCANNER receive FDA 510(k) clearance?

INTERAD WHOLE BODY CT SCANNER received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813162.

Who is the listed applicant for INTERAD WHOLE BODY CT SCANNER?

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

What is the FDA product code for INTERAD WHOLE BODY CT SCANNER?

The FDA product code for INTERAD WHOLE BODY CT SCANNER is JAK.

Related Clinical Trials

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.

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Other records listing Interad Systems, Inc. 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.

K834087MODEL XLEK834307ULTRASOUND SCANNER XLK833821INTERAD 520

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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