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FDA 510(k)

SCANNERS, TOMOGRAPHIC, COMPUTED

K-Number: K780115 · 1978-01-30

ApplicantOhio Nuclear, Inc.
Decision Date1978-01-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANNERS, TOMOGRAPHIC, COMPUTED is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Nuclear, Inc.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K780115. 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 SCANNERS, TOMOGRAPHIC, COMPUTED?

SCANNERS, TOMOGRAPHIC, COMPUTED is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Ohio Nuclear, Inc.. The 510(k) number is K780115.

When did SCANNERS, TOMOGRAPHIC, COMPUTED receive FDA 510(k) clearance?

SCANNERS, TOMOGRAPHIC, COMPUTED received FDA 510(k) clearance on 1978-01-30, under 510(k) number K780115.

Who is the listed applicant for SCANNERS, TOMOGRAPHIC, COMPUTED?

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

What is the FDA product code for SCANNERS, TOMOGRAPHIC, COMPUTED?

The FDA product code for SCANNERS, TOMOGRAPHIC, COMPUTED is JAK.

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Other records listing Ohio Nuclear, 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.

K792603COMPUTED TOMOGRAPHY X-RAY SCANNERK791195DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCANK781079SONOGRAF ULTRASOUND B-SCANNING SYSTEMK780165PROCESSOR, VIDEO IMAGE VIP-550K772305RAD. THERAPY PLANNING SUP. SYS.K771082DELTASCAN 2000 SERIES

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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

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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