Identity
- Trade Name
- System BreastSTEP Prone US FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Model / Reference
- P10107-725 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120074397255 FDA UDI
- 510(k) Number
- K081218 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
System BreastSTEP Prone US by IT-V Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K081218 also covers:
- BellySTEP Baseplate — IT-V Medizintechnik GmbH
- BellySTEP Baseplate cut out long — IT-V Medizintechnik GmbH
- BellySTEP Baseplate no cut out — IT-V Medizintechnik GmbH
- BellySTEP Insert A - Medium — IT-V Medizintechnik GmbH
- BreastSTEP Mask 2mm (5 pcs.) — IT-V Medizintechnik GmbH
- Distance Plate PushPIN — IT-V Medizintechnik GmbH
- FoamSTEP Comfort Module Grey 180 x 45 x 3cm — IT-V Medizintechnik GmbH
- FoamSTEP Roll 300 x 70 Dm — IT-V Medizintechnik GmbH
- FoamSTEP Semiroll 400 x 220 x 220 Dm (H110) — IT-V Medizintechnik GmbH
- FoamSTEP Wedge 130 x 250 x 60 to 0 — IT-V Medizintechnik GmbH
- GreyBAG Adapter — IT-V Medizintechnik GmbH
- HS Independent Indexing Clamp 500, Offcentered — IT-V Medizintechnik GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IT-V Medizintechnik GmbH
Sources (2)
- FDA UDI 70529abc-e55c-444d-9eb7-1d253e30b3ac 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026