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FDA 510(k)

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

K-Number: K872132 · 1987-10-26

ApplicantSopha Medical Systems, Inc.
Decision Date1987-10-26
Product CodeIXY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sopha Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-10-26 under 510(k) number K872132. The device is classified under product code IXY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS?

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Sopha Medical Systems, Inc.. The 510(k) number is K872132.

When did SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS receive FDA 510(k) clearance?

SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS received FDA 510(k) clearance on 1987-10-26, under 510(k) number K872132.

Who is the listed applicant for SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS?

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

What is the FDA product code for SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS?

The FDA product code for SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS is IXY.

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Other records listing Sopha Medical 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.

K952190TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGEK942837DST-XLK921008VECTOR SERIESK913641SOPHY NXTK911346SOPHYCAMERA DSX BODYTRAKK894931SOPHYCAMERA DSX RECTANGULAR

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Related Devices (Code: IXY)

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.

K953402UNIVERSIX 190Philips Medical Systems (Cleveland), Inc.K953336VRS 3 WALL STANDPhilips Medical Systems (Cleveland), Inc.K946114SENSORI-MOTOR RATING SCALECmedK946260NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.K930249BC/WT/PFTingle X-Ray Products, Inc.K930230RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDERAmerican Medical Sales, 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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