Identity
- Trade Name
- COMPACT TOUCH FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means. FDA UDI
- Model / Reference
- COMPACT TOUCH 2017 FDA UDI
- Description
- Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625545 FDA UDI
- 510(k) Number
- K180265 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
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
No
FDA UDI
Category: Ophthalmic ultrasound imaging system
Compact Touch by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic ultrasound imaging system.
- A-scan probe — Nidek, Inc. · Class II
- ArcScan Insight 100 — Arcscan, Inc. · Class II
- Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
- Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
- B-scan Plus- VET — ACCUTOME, INC. · Class II
Cleared under the same submission
K180265 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 |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA UDI 1d208c58-127b-41a3-9726-f5c4a7780f77 35 fields · synced May 30, 2026