Identity
- Trade Name
- Polaroid DDS FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Device Name
- Polaroid DDS software FDA UDI
- Model / Reference
- V8 FDA UDI
- Description
- Polaroid DDS software FDA UDI
Identifiers
- Catalog Number
- PDDS FDA UDI
- Primary DI / UDI-DI
- 10667147001542 FDA UDI
- 510(k) Number
- K062237 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology information system application software
Polaroid DDS by Synca Marketing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology information system application software.
- Orpheus CAST App — ORPHEUS MEDICAL LTD · Class II
- eRAD RIS — Erad, Inc. · Class II
- RamSoft — Ramsoft Inc · Class II
- Roentgen Works — BRIT SYSTEMS · Class II
- Pre-Sure — Lazarus 3D · Class II
- Gendex VixWin™ imaging software — GENDEX CORP. · Class II
- InvivoMac — ANATOMAGE, INC. · Class II
- Roentgen Works — BRIT SYSTEMS · Class I
Cleared under the same submission
K062237 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Synca Marketing Inc
Sources (1)
- FDA UDI 8d123377-d263-41f6-9bba-ed506d1ebae8 35 fields · synced Jun 8, 2026