Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SpectoMed (v1.0)

K-Number: K242205 · 2025-01-14

ApplicantSpecto Medical
Decision Date2025-01-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpectoMed (v1.0) is a medical device manufactured by Specto Medical. It received FDA 510(k) clearance on 2025-01-14 under approval number K242205. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpectoMed (v1.0)?

SpectoMed (v1.0) is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Specto Medical. The 510(k) number is K242205.

When was SpectoMed (v1.0) approved by the FDA?

SpectoMed (v1.0) received FDA 510(k) clearance on 2025-01-14, under approval number K242205.

What company makes SpectoMed (v1.0)?

SpectoMed (v1.0) is manufactured by Specto Medical.

What is the FDA product code for SpectoMed (v1.0)?

The FDA product code for SpectoMed (v1.0) is LLZ.

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, 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.

↑