Visionstar ODM-2100

Ophthalmology clinics performing B-scan work under a practical constraint that the specification sheet does not describe: both hands are occupied. One steadies the probe against the eye, the other frequently supports or reassures the patient, and neither is available for the console. Foot switch operation removes that constraint, allowing freeze and capture without breaking contact or asking an assistant to press keys. Product imagery shows a foot switch, and Medigear.uk confirms whether it forms part of standard supply.

Services procuring against a documented audit trail are well served here. The manufacturer holds an FDA 510(k) clearance for 10 MHz A-scan and B-scan that specifically names the ODM-2100. That clearance is traceable to a regulator's own document because it appears as a cited predicate in a separate manufacturer's submission. For procurement that must evidence provenance rather than accept a badge, this is a stronger position than most equipment in the class offers.

Posterior segment assessment benefits from depth adjustment across 34 to 60 mm with eight zoom steps and a variable display area, alongside five-segment time gain compensation that independently balances near-, mid-, and far-field. Cineloop allows a sweep to be reviewed rather than judged on the frozen frame, which is how B-scan findings are most reliably identified. All interpretation remains with the practitioner.

Cataract planning uses the supplied 10 MHz A-mode biometric probe, with axial length biometric measurement stated among the intended applications. Both probes ship as standard, so biometry is available from delivery rather than requiring a separate purchase and a second supplier conversation.

Named Directly on the FDA Clearance

The manufacturer's 510(k) clearance K063433 for 10 MHz A-scan and B-scan specifically names the ODM-2100, and it is traceable to a regulator's own document because a separate manufacturer cites it as a predicate device. Being able to verify a clearance rather than accept a claim is uncommon in this segment and useful wherever procurement must evidence provenance.

Foot Switch Keeps Both Hands Working

B-scan occupies both hands, one on the probe and often the other supporting the patient, leaving nothing for the console. Operating freeze and capture from a pedal removes that constraint without needing a second person. This changes how an examination runs rather than how it reads on paper. Medigear.uk confirms whether the switch is standard supply.

Trackball for Calliper Placement

Measurement means positioning callipers precisely on an image, and a trackball does that far more directly than cursor keys, while standing up better to repeated clinical use than a touchpad. Distance measurement and image post-processing are both provided.

Both Probes Supplied as Standard

The 10 MHz mechanical sector B probe and the 10 MHz A-mode biometric probe are both included. Hence, imaging and biometry work right out of the box rather than requiring a second purchase. Medigear.uk issues a written inclusion list at quotation.

Depth Adjustable From 34 to 60 mm

Variable depth with eight zoom steps and a variable display area matches the field to the examination rather than always scanning to maximum, devoting more of the display to the region of interest. Fixed-depth instruments impose that compromise permanently.

Five-Segment Manual Time Gain Compensation

TGC adjustable across five separate segments from −30 dB to 0 dB balances near-, mid-, and far-field independently rather than applying a single correction across the whole depth. That matters when a finding sits at a different depth than the surrounding structures.

Cineloop Review Rather Than a Single Frame

B-scan is a sweep, and the clearest view of a finding is often not the frame captured at the moment of freezing. Cineloop retains the sequence for review afterwards, so the examination is based on the best image, and repeat sweeps are avoided. Medigear.uk confirms the frame count retained.

Display Type and Market Position Confirmed Before Order

One published description references a non-interlaced CRT monitor, which, if current, carries consequences for weight, power, screen life, and parts availability. An FDA clearance is also a United States position rather than the marking applicable here. Medigear.uk resolves both in writing and verifies CE and ISO 13485 documentarily before supply.

Foot Switch Operation

Product imagery shows a foot switch alongside the console, allowing freeze and capture without a free hand. Whether it forms part of the standard supply is confirmed in the quotation.

Trackball Control

A trackball provides measurement and navigation rather than cursor keys, offering direct calliper placement and durability during repeated use.

Foldable Keypad

The keypad folds against the unit for transport and opens for use, giving different stored and working footprints on a console instrument.

Built-In Monitor

The console carries an integrated monitor. Display type is confirmed with Medigear.uk before order, since published descriptions reference a CRT.

Two Probes Supplied as Standard

A 10 MHz mechanical sector B probe and a 10 MHz A-mode biometric probe are both included in the standard set.

B-Scan Mechanical Sector Scanning

B-scan uses mechanical sector scanning at 10 MHz. Probe service life and replacement availability are confirmed in the quotation, since mechanical probes are wear components.

Depth Range: 34 to 60 mm

Scan depth is variable from 34 to 60 mm rather than fixed, allowing the field to be matched to the examination.

Zoom in Eight Steps with Variable Display Area

Zoom operates across eight steps within the depth range, with a variable display area providing further control over how the field is presented.

Scanning Angle: 53 Degrees

The sector scanning angle is 53 degrees, which, together with the depth, defines the field captured in a single sweep.

Gain Control: 0 to 98 dB

Gain adjusts across a 98 dB range, providing latitude across structures of differing reflectivity within the posterior segment.

Five-Segment Manual TGC

Time gain compensation is manually adjustable from −30 dB to 0 dB across five segments, allowing depth-dependent correction rather than a single global setting.

Resolution and Geometric Accuracy

Resolution is 0.2 mm axial and 0.4 mm lateral, with geometric position accuracy of 5 per cent axial and 10 per cent lateral.

Four Display Modes

Display modes cover B, B+B, B+A and A, allowing imaging and biometry to be shown separately or together.

Cineloop and Image Memory

Cineloop retains a frame sequence for review after acquisition, with memory for up to four images. The retained frame count is confirmed with the manufacturer.

Image Post-Processing and Distance Measurement

Post-processing and distance measurement are provided on captured images, with the trackball used for calliper placement.

Named on the Manufacturer's FDA Clearance

MEDA CO., LTD holds 510(k) clearance K063433 for the 10 MHz A-scan and B-scann,designated ODM-2100. Medigear.uk obtains the documentation and confirms the applicable marking position for supply.

Display Type and Certification Position

Published descriptions reference a non-interlaced CRT monitor, and the current display type is confirmed before order alongside documentary evidence for CE and ISO 13485.

The Visionstar ODM-2100 Ophthalmic Scanner is a full-function A/B console supplied complete with 10 MHz mechanical sector B and 10 MHz A-mode biometric probes, a foldable keypad, trackball and foot switch operation, offering depth variable from 34 to 60 mm across eight zoom steps, gain to 98 dB, five-segment time gain compensation and cineloop review. It is named directly in the manufacturer MEDA's FDA 510(k) clearance for 10 MHz A-scan and B-scan, which is traceable to a regulator's own document rather than a sales listing, suiting ophthalmology clinics performing B-scan when both hands are occupied, cataract planning services, and procurement processes requiring evidenced provenance. Display type, foot switch supply, and the marking position applicable to supply and warranty routing are all confirmed in writing before order. Contact Medigear.uk for specifications, procurement assistance, or expert consultation.