Standard Imaging Hdr 1000 Plus Ion Chamber +1 more model

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K001825

Identifiers

510(k) Number: K001825 FDA 510(k)
FDA Product Code: JAQ FDA 510(k)
Models / Variants: Standard Imaging Hdr 1000 Plus Ion Chamber FDA 510(k)EUDAMED
Standard Imaging Ivb 1000 Ion Chamber FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.5700 FDA 510(k)
Regulation Number: 892.5700 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Standard Imaging Hdr 1000 Plus Ion Chamber +1 more model by Standard Imaging, Inc. — Class II — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — 2 models

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K001825	Class II	Active

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Manufacturer

Manufacturer: Standard Imaging, Inc.

Sources (2)

FDA 510(k) K001825 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026