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Standard Imaging Pipspro Qa Software System

FDA 510(k)FDA UDIEUDAMED

Class I (US FDA 510(k))

510(k) K042733Ref 91309

by Standard Imaging, Inc.

Identity

Trade Name
PIPSpro EUDAMED
Standard Imaging PIPSpro Software FDA UDI
Generic Name
Radiation therapy software FDA UDI
Device Name
PIPSpro EUDAMED
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems. FDA UDI
Model / Reference
91309 EUDAMED
v5 FDA UDI
Description
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems. FDA UDI

Identifiers

Catalog Number
91309 FDA UDI
Primary DI / UDI-DI
00866562000236 EUDAMEDFDA UDI
Basic UDI-DI
08665620002PIPSPROPX EUDAMED
510(k) Number
K042733 FDA 510(k)FDA UDI
FDA Product Code
LHO FDA 510(k)FDA UDI
IYE FDA UDI
IXG FDA UDI
LLZ FDA UDI
LMB FDA UDI
LMD FDA UDI
EMDN Code
Z11010182 LINEAR ACCELERATORS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
Radiation therapy software FDA UDI

Classification

Device Class
Class I EUDAMEDFDA 510(k)
Class II FDA UDI
Legislation / Framework
21 CFR Part 892.1940 FDA 510(k)
Regulation Number
892.1940 FDA 510(k)FDA UDI
892.5050 FDA UDI
892.1950 FDA UDI
892.2050 FDA UDI
892.2010 FDA UDI
892.2020 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
France EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Standard Imaging Pipspro Qa Software System by Standard Imaging, Inc. — Class I — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Standard Imaging, Inc.

Sources (3)

  • FDA 510(k) K042733 24 fields · synced Jul 11, 2026
  • FDA UDI 186d9f3b-ac9e-4f27-a9e2-131c5d4c8a32 35 fields · synced May 30, 2026
  • EUDAMED 5519544e-38fc-4250-9526-405d0d343cbd 61 fields · synced Jul 11, 2026