Evolve Slant Board

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref OAP200Model Breast Positioning Devices

by Medtec LLC

Identity

Trade Name: Evolve Slant Board FDA UDI
Generic Name: Radiological breast positioner, non-wearable FDA UDI
Device Name: For use with Evolve breastboard solution FDA UDI
Model / Reference: OAP200 EUDAMEDFDA UDI
Breast Positioning Devices EUDAMED
Description: For use with Evolve breastboard solution FDA UDI

Identifiers

Catalog Number: OAP200 FDA UDI
Primary DI / UDI-DI: 00841439114155 EUDAMEDFDA UDI
Basic UDI-DI: 8414391OC0010R019Y EUDAMED
510(k) Number: K211001 FDA UDI
FDA Product Code: LNH FDA UDI
IYE FDA UDI
EMDN Code: Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Radiological breast positioner, non-wearable FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
892.5050 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological breast positioner, non-wearable

Evolve Slant Board by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiological breast positioner, non-wearable.

MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
SenoView Prone Breast Board — Aktina Corp. · Class II
MammoPad Radiolucent Cushion — Hologic, Inc. · Class II
Quest™ — Qfix · Class II
Access™ Supine — Qfix · Class II
Breast Riser CX — QUALITY ELECTRODYNAMICS LLC · Class I
ArmCradle4 — Aktina Corp. · Class II

Cleared under the same submission

K211001 also covers:

Evolve Bottom Board — Medtec LLC
Evolve Type-S™ Locating Bar — Medtec LLC
Molded Hand Grip — Medtec LLC
Pro Handle — Medtec LLC
Pro Wing Board™ — Medtec LLC

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtec LLC

Sources (2)

FDA UDI 733ab13d-98a0-45ba-b6b4-e553fab5b02e 36 fields · synced Jul 16, 2026
EUDAMED 2d679c69-31f3-4947-8492-d91a579c6ef1 61 fields · synced Jul 16, 2026