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FDA 510(k)

Synapse PACS (7.6.0)

K-Number: K261713 · 2026-06-18

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2026-06-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse PACS (7.6.0) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261713. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synapse PACS (7.6.0)?

Synapse PACS (7.6.0) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K261713.

When did Synapse PACS (7.6.0) receive FDA 510(k) clearance?

Synapse PACS (7.6.0) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261713.

Who is the listed applicant for Synapse PACS (7.6.0)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapse PACS (7.6.0)?

The FDA product code for Synapse PACS (7.6.0) is QIH.

Other records listing FUJIFILM Healthcare Americas Corporation 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.

K251204FUJIFILM Stiffening Wire Device (SW-2000)K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CK233629APERTO Lucent MRI SystemK233687ECHELON Synergy V10.0K233583FCT iSTREAM Phase 1

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Related Devices (Code: QIH)

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.

K253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.K261349SwiftMRAirs Medical, Inc.K260192DIANAROPCA ApSK254096VELMENI for DENTISTS (V4D) 3DVelmeni, 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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