Is this your brand? Sign in to claim ownership.

STANDARD IMAGING, INC.

United States·US-MF-000009855

Last updated September 17, 2026

Information

Country: United States
Address: 3120, Deming Way, Middleton, United States
Website: www.standardimaging.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 608-824-7807
PRRC Contact: Ellen Lindquist
EUDAMED SRN: US-MF-000009855
FDA FEI Number: 1000115748
DUNS Number: —

Catalogue (80)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Standard Imaging Exradin A14 Ion Chamber	92711	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A1SLMR Ion Chamber	92900	FDA UDI	Class I	Active
Standard Imaging Exradin A26MR Ion Chamber	92901	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Reconstruction Jig Large	91280	EUDAMEDFDA UDI	Class I	Active
Standard Imaging TomoElectrometer	90016	EUDAMEDFDA UDI	Class I	Active
Standard Imaging TomoScanner	91750	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin M2 Ion Chamber with Gas Flow	92742	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Adaptivo	v1	EUDAMEDFDA UDI	Class II	Active
Standard Imaging Exradin A4 Ion Chamber	92715	FDA UDI	Class I	Active
Standard Imaging Exradin A11TW Ion Chamber	92708	FDA UDI	Class I	Active
Standard Imaging Exradin A3 Ion Chamber	92717	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A5 Ion Chamber	92724	EUDAMEDFDA UDI	Class I	Active
Standard Imaging IMRT Dose Verification Phantom	91230	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A18 Ion Chamber	92729	FDA UDI	Class I	Active
Standard Imaging Exradin A12S Ion Chamber	92725	EUDAMEDFDA UDI	Class I	Active
Standard Imaging DoseView 3D	92260	EUDAMEDFDA UDI	Class II	Active
Standard Imaging Exradin A28 Ion Chamber	92749	FDA UDI	Class I	Active
Standard Imaging Exradin A19 Ion Chamber	92734	FDA UDI	Class I	Active
Standard Imaging Exradin A28MR Ion Chamber	92902	EUDAMEDFDA UDI	Class I	Active
Standard Imaging Exradin A1 Ion Chamber	92705	FDA UDI	Class I	Active
Standard Imaging Hdr 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber	K001825	FDA 510(k)	Class II	Active
Standard Imaging Hdr 1000 Ion Chamber	K922554	FDA 510(k)	Class II	Active
Stand Imaging Dose Calibrator Shielded Work Platform	K940539	FDA 510(k)	Class I	Active
Standard Imaging Ivb 1000 Well Chamber	K013548	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Hdr 1000 Plus Well Chamber, Model 90008	K060532	FDA 510(k)	Class II	Active
Standard Imaging Pipspro Qa Software System	K042733	EUDAMEDFDA 510(k)FDA UDI	Class I	Active
Modification To Standard Imaging Pt 1000 Ion Chamber	K002833	FDA 510(k)	Class II	Active
Standard Imaging E.imrt Calculator	K040688	FDA 510(k)	Class II	Active
Doseview 3d	K103193	FDA 510(k)	Class II	Active
Standard Imaging Imsure Brachy Qa Software, Model 91331	K082773	EUDAMEDFDA 510(k)FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 28, 2003	Z-0952-03	—	terminated	Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.