declipse®SPECT declipseSPECT Viewer

by Surgiceye GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberESURSE13010002 UDI-DI	Date17 Jan 2018Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: declipse®SPECT
Generic Name: Scintillation radiation measuring probe
Model / Ref / Catalog: declipseSPECT Viewer, SE 1301-0002

Primary DI / UDI-DI: ESURSE13010002
510(k) Number: K123917
FDA Product Code: IZD
GMDN Term: Scintillation radiation measuring probe

Device Class: Class I
Regulation Number: 892.1320
GUDID distribution status: In Commercial Distribution

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Properties

Serial Number
Manufacturing Date

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No