D-SPECT Scanner, D-SPECT L Scanner
K-Number: K161740 · 2016-11-04
Device Summary
Frequently Asked Questions
What is the D-SPECT Scanner, D-SPECT L Scanner?
D-SPECT Scanner, D-SPECT L Scanner is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K161740.
When did D-SPECT Scanner, D-SPECT L Scanner receive FDA 510(k) clearance?
D-SPECT Scanner, D-SPECT L Scanner received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161740.
Who is the listed applicant for D-SPECT Scanner, D-SPECT L Scanner?
The FDA 510(k) record lists Spectrum Dynamics Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for D-SPECT Scanner, D-SPECT L Scanner?
The FDA product code for D-SPECT Scanner, D-SPECT L Scanner is KPS.
Other records listing Spectrum Dynamics Medical, Ltd. 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.
Related Devices (Code: KPS)
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.
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.