FDA 510(k)

DST-XL

K-Number: K942837 · 1995-01-05

Decision Date1995-01-05

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DST-XL 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 1995-01-05 under 510(k) number K942837. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DST-XL?

DST-XL is a medical device that received FDA 510(k) clearance on 1995-01-05. The listed applicant is Sopha Medical Systems, Inc.. The 510(k) number is K942837.

When did DST-XL receive FDA 510(k) clearance?

DST-XL received FDA 510(k) clearance on 1995-01-05, under 510(k) number K942837.

Who is the listed applicant for DST-XL?

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 DST-XL?

The FDA product code for DST-XL is KPS.

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) PACKAGE K921008VECTOR SERIES K913641SOPHY NXT K911346SOPHYCAMERA DSX BODYTRAK K894931SOPHYCAMERA DSX RECTANGULAR K872132SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

View all 8 devices →

Related Devices (Code: KPS)

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.