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FDA 510(k)

SONOGRAF ULTRASOUND B-SCANNING SYSTEM

K-Number: K781079 · 1978-07-17

ApplicantOhio Nuclear, Inc.
Decision Date1978-07-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOGRAF ULTRASOUND B-SCANNING SYSTEM 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 1978-07-17 under 510(k) number K781079. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOGRAF ULTRASOUND B-SCANNING SYSTEM?

SONOGRAF ULTRASOUND B-SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Ohio Nuclear, Inc.. The 510(k) number is K781079.

When did SONOGRAF ULTRASOUND B-SCANNING SYSTEM receive FDA 510(k) clearance?

SONOGRAF ULTRASOUND B-SCANNING SYSTEM received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781079.

Who is the listed applicant for SONOGRAF ULTRASOUND B-SCANNING SYSTEM?

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 SONOGRAF ULTRASOUND B-SCANNING SYSTEM?

The FDA product code for SONOGRAF ULTRASOUND B-SCANNING SYSTEM is IYO.

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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 SCANK780165PROCESSOR, VIDEO IMAGE VIP-550K780115SCANNERS, TOMOGRAPHIC, COMPUTEDK772305RAD. THERAPY PLANNING SUP. SYS.K771082DELTASCAN 2000 SERIES

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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